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Clinical Evaluation of the OEC Elite MD for Vascular Procedures at Hamilton General Hospital

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ClinicalTrials.gov Identifier: NCT03417713
Recruitment Status : Completed
First Posted : January 31, 2018
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Interventional Vascular Conditions
Intervention Device: Fluoroscopic imaging with the OEC Elite Device
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Subjects
Hide Arm/Group Description

This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.

Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

Period Title: Overall Study
Started 33
Completed 30
Not Completed 3
Arm/Group Title All Subjects
Hide Arm/Group Description

This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.

Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
69.9
(55 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
9
  30.0%
Male
21
  70.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Image Guidance Adequacy Collected Via Survey Questionnaire
Hide Description Number of participants whose procedures were completed using the investigational device.
Time Frame Approximately 2 months (duration of subject enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.

Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
2.Secondary Outcome
Title Number of Investigator Procedure Surveys Assessed by Survey Questionnaire
Hide Description To collect image data acquired during clinical procedures and to collect investigator feedback via surveys on the use of the system during clinical procedures.
Time Frame Approximately 2 months (duration of subject enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects
Hide Arm/Group Description:

This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.

Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
Time Frame Adverse events were collected from when the subject entered the study to when they completed study procedures
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects
Hide Arm/Group Description

This group/cohort is expected to be representative of the general population that would require mobile fluoroscopic imaging with C-arm devices, such as OEC Elite.

Fluoroscopic imaging with the OEC Elite Device: Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.

All-Cause Mortality
All Subjects
Affected / at Risk (%)
Total   0/30 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Subjects
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Skin and subcutaneous tissue disorders   
Hematoma *  1/30 (3.33%)  1
*
Indicates events were collected by non-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
Name/Title: Dr. Theodore Rapanos
Organization: Hamilton General Hospital
Phone: 905-521-2100 ext 44652
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03417713     History of Changes
Other Study ID Numbers: 104-2017-GES-0005
First Submitted: January 12, 2018
First Posted: January 31, 2018
Results First Submitted: July 11, 2018
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018