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A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping (FILM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02209532
Recruitment Status : Completed
First Posted : August 6, 2014
Results First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Novadaq Technologies ULC, now a part of Stryker

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Endometrial Cancer
Uterine Cancer
Cervical Cancer
Intervention Device: PINPOINT
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lymph Node Mapping With Isosulfan Blue Followed by PINPOINT Lymph Node Mapping With PINPOINT Followed by Isosulfan Blue
Hide Arm/Group Description

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Period Title: Overall Study
Started 90 90
Completed 87 89
Not Completed 3 1
Arm/Group Title Blue - PINPOINT PINPOINT - Blue Total
Hide Arm/Group Description

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Total of all reporting groups
Overall Number of Baseline Participants 87 89 176
Hide Baseline Analysis Population Description
180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment) therefore, 176 subjects were included in the Baseline analysis population.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
30-39
3
   3.4%
4
   4.5%
7
   4.0%
40-49
6
   6.9%
4
   4.5%
10
   5.7%
50-59
20
  23.0%
26
  29.2%
46
  26.1%
60-69
33
  37.9%
41
  46.1%
74
  42.0%
70-79
20
  23.0%
12
  13.5%
32
  18.2%
>80
5
   5.7%
2
   2.2%
7
   4.0%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Female Number Analyzed 87 participants 89 participants 176 participants
87
 100.0%
89
 100.0%
176
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
White
66
  75.9%
73
  82.0%
139
  79.0%
Black or African American
5
   5.7%
2
   2.2%
7
   4.0%
Asian
4
   4.6%
2
   2.2%
6
   3.4%
Other
2
   2.3%
0
   0.0%
2
   1.1%
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
Never
66
  75.9%
65
  73.0%
131
  74.4%
Current
2
   2.3%
5
   5.6%
7
   4.0%
Past
19
  21.8%
19
  21.3%
38
  21.6%
Alcohol Consumption  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
Yes
34
  39.1%
31
  34.8%
65
  36.9%
No
53
  60.9%
58
  65.2%
111
  63.1%
ASA Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
I - A normal healthy patient
10
  11.5%
11
  12.4%
21
  11.9%
II - A patient with mild systemic disease
38
  43.7%
39
  43.8%
77
  43.8%
III - A patient with severe systemic disease
34
  39.1%
32
  36.0%
66
  37.5%
Unknown ASA Classification
5
   5.7%
7
   7.9%
12
   6.8%
Preoperative Diagnosis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
Stage 1 Endometrial Cancer
84
  96.6%
85
  95.5%
169
  96.0%
Stage 1 Cervical Cancer
2
   2.3%
2
   2.2%
4
   2.3%
Stage 1A Cervical Cancer
3
   3.4%
2
   2.2%
5
   2.8%
Endometrial Cancer Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
Adenocarcinoma
71
  81.6%
75
  84.3%
146
  83.0%
Serous Carcinoma
7
   8.0%
6
   6.7%
13
   7.4%
Clear Cell Carcinoma
4
   4.6%
0
   0.0%
4
   2.3%
Carcinosarcoma
1
   1.1%
2
   2.2%
3
   1.7%
Other
1
   1.1%
2
   2.2%
3
   1.7%
Cervical Cancer Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 89 participants 176 participants
Squamous Cell Carcinoma
0
   0.0%
3
   3.4%
3
   1.7%
Adenocarcinoma
3
   3.4%
1
   1.1%
4
   2.3%
1.Primary Outcome
Title Effectiveness of PINPOINT and IC2000 in the Identification of Lymph Nodes Defined as the Proportion of Confirmed Lymph Nodes Identified
Hide Description To assess the effectiveness of intraoperative PINPOINT Near Infrared Fluorescence Imaging in the identification of lymph nodes in subjects with uterine and cervical malignancies who are undergoing lymph node mapping.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
All analyses were completed using the number of lymph nodes identified.
Arm/Group Title PINPOINT - Blue Blue - PINPOINT
Hide Arm/Group Description:

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Overall Number of Participants Analyzed 82 81
Overall Number of Units Analyzed
Type of Units Analyzed: Confirmed Lymph Nodes
238 247
Measure Type: Number
Unit of Measure: Confirmed Lymph Nodes
232 239
2.Secondary Outcome
Title Effectiveness of PINPOINT and Blue Dye in the Identification of at Least One Lymph Node Defined as the Number of Subjects in Which at Least One Confirmed Lymph Node Was Identified With Either PINPOINT or Blue Dye
Hide Description To evaluate the effectiveness of PINPOINT and Blue dye in the identification of at least one lymph node (confirmed to be lymphoid tissue) per subject.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
Arm/Group Title PINPOINT-Blue Blue - PINPOINT
Hide Arm/Group Description:

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Overall Number of Participants Analyzed 82 81
Measure Type: Number
Unit of Measure: Number of Subjects
IC2000 and PINPOINT 80 79
Isosulfan Blue 64 60
3.Secondary Outcome
Title Effectiveness of PINPOINT and Blue Dye in the Identification of Bilateral Lymph Nodes Defined as the Number of Subjects in Which Lymph Nodes Were Identified Bilaterally With Either PINPOINT or Blue Dye.
Hide Description To evaluate the effectiveness of PINPOINT and Blue dye in the identification of bilateral lymph nodes (confirmed to be lymphoid tissue).
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
Arm/Group Title PINPOINT-Blue Blue - PINPOINT
Hide Arm/Group Description:

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Overall Number of Participants Analyzed 82 81
Measure Type: Number
Unit of Measure: Number of Subjects
IC2000 and PINPOINT 64 60
Isosulfan Blue 24 25
4.Secondary Outcome
Title Identification of Lymph Nodes Following Lymphatic Channels Defined as the Number of Subjects in Which Confirmed Lymph Nodes Were Identified by Following a Lymphatic Channel With Either PINPOINT or Blue Dye.
Hide Description To determine the proportion of lymph nodes identified from following lymphatic channels
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
Arm/Group Title PINPOINT-Blue Blue - PINPOINT
Hide Arm/Group Description:

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Overall Number of Participants Analyzed 82 81
Measure Type: Number
Unit of Measure: Number of Subjects
IC2000 and PINPOINT 6 3
Isosulfan Blue 8 6
5.Secondary Outcome
Title Safety of Interstitial Injection of ICG Defined as the Number of Adverse Effects Related to ICG
Hide Description To assess the safety of interstitial injection of ICG for intraoperative lymphatic mapping, as measured by number of subjects experiencing adverse effects related to the study treatment.
Time Frame Day 0 to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
Arm/Group Title PINPOINT-Blue Blue - PINPOINT
Hide Arm/Group Description:

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Overall Number of Participants Analyzed 89 87
Measure Type: Number
Unit of Measure: Number of subjects
0 0
6.Secondary Outcome
Title Anatomic Distribution of Lymph Nodes
Hide Description To determine the anatomic distribution of lymph nodes
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
180 subjects were randomized. 4 subjects were found to be ineligible after randomization (subjects did not receive study treatment). Of the 176 subjects randomized who completed the study, 13 had significant protocol deviations. Thus, 163 subjects are included in the analysis population (81 subjects in the B-P arm and 82 subjects in the P-B arm).
Arm/Group Title PINPOINT-Blue Blue - PINPOINT
Hide Arm/Group Description:

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

Overall Number of Participants Analyzed 82 81
Overall Number of Units Analyzed
Type of Units Analyzed: Lymph Nodes
232 239
Measure Type: Number
Unit of Measure: confirmed lymph nodes
Left obturator/internal iliac 28 36
Left external iliac 69 67
Left common iliac 11 6
Right obturator/internal iliac 39 45
Right external iliac 52 50
Right common iliac 17 18
Presacral 2 5
Para-aortic node below IMA 4 5
Other 10 7
Time Frame 30 Days
Adverse Event Reporting Description Adverse Events were not monitored/assessed for each intervention separately. Both interventions (ICG/PINPOINT and Isosulfan Blue) were administered at the time of the adverse events.
 
Arm/Group Title Blue - PINPOINT PINPOINT - Blue
Hide Arm/Group Description

The cervix will be injected 4 times with a 1ml solution of 1% Isosulfan blue followed by injection 4 times of 1 ml of 1.25 mg/ml solution of ICG. LN mapping with Blue dye will be performed until the investigator identifies all blue nodes or determines that blue nodes cannot be identified. Once complete, the Investigator will begin mapping with PINPOINT until all ‘ICG’ nodes are identified or the investigator determines that ‘ICG’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

The cervix will be injected 4 times with 1 ml of a 1.25 mg/ml solution of ICG followed by injection 4 times of a 1 ml solution of 1% Isosulfan blue. LN mapping with PINPOINT will be performed until the investigator identifies all ‘ICG’ nodes or determines that ‘ICG’ nodes cannot be identified. Once complete, the Investigator will begin mapping with Blue dye until all ‘blue’ nodes are identified or the investigator determines that ‘blue’ nodes cannot be identified. Once mapping with both Blue dye and PINPOINT have been completed and documented, LNs identified with Blue dye or PINPOINT will be excised.

PINPOINT: PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes

All-Cause Mortality
Blue - PINPOINT PINPOINT - Blue
Affected / at Risk (%) Affected / at Risk (%)
Total   0/87 (0.00%)   0/89 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Blue - PINPOINT PINPOINT - Blue
Affected / at Risk (%) Affected / at Risk (%)
Total   4/87 (4.60%)   1/89 (1.12%) 
Ear and labyrinth disorders     
Vertigo   0/87 (0.00%)  1/89 (1.12%) 
Gastrointestinal disorders     
Partial bowel obstruction   1/87 (1.15%)  0/89 (0.00%) 
Nervous system disorders     
Dizziness   1/87 (1.15%)  0/89 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis   1/87 (1.15%)  0/89 (0.00%) 
Trace pleural effusions   1/87 (1.15%)  0/89 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Blue - PINPOINT PINPOINT - Blue
Affected / at Risk (%) Affected / at Risk (%)
Total   13/87 (14.94%)   10/89 (11.24%) 
Gastrointestinal disorders     
Nausea   7/87 (8.05%)  4/89 (4.49%) 
Injury, poisoning and procedural complications     
Procedural Pain   13/87 (14.94%)  10/89 (11.24%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alicia Wilton
Organization: Novadaq Technologies
Phone: 416-949-4992
EMail: alicia.wilton@stryker.com
Layout table for additonal information
Responsible Party: Novadaq Technologies ULC, now a part of Stryker
ClinicalTrials.gov Identifier: NCT02209532     History of Changes
Other Study ID Numbers: PP LNM 01
First Submitted: July 29, 2014
First Posted: August 6, 2014
Results First Submitted: November 19, 2018
Results First Posted: March 25, 2019
Last Update Posted: March 25, 2019