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Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy (DONTBIOPCE)

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: NCT00795184
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : May 3, 2016
Last Update Posted : May 3, 2016
Sponsor:
Collaborators:
Cellvizio Inc.
Emissary International LLC
Information provided by (Responsible Party):
Mauna Kea Technologies

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Barrett Syndrome
Barrett's Syndrome
Barrett's Esophagus
Barrett Esophagus
Adenocarcinoma
Interventions Device: Imaging procedures (NBI)
Device: HDWLE
Device: pCLE
Enrollment 122
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HDWLE First NBI Second and pCLE NBI First HDWLE Second and pCLE
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 65 57
Completed 57 [1] 44 [2]
Not Completed 8 13
Reason Not Completed
Tissue sampling incomplete/conclusive             8             13
[1]
57 patients analysable, completed all 3 imaging procedures
[2]
44 patients analysable, completed all 3 imaging procedures
Arm/Group Title Group 1
Hide Arm/Group Description NBI-pCLE
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
65.1  (11.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
14
  13.9%
Male
87
  86.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 101 participants
France 9
United States 62
Germany 30
1.Primary Outcome
Title Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Hide Description Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Time Frame Centralized histopathology confirmation within 4-6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HDWLE NBI (Narrow Band Imaging) pCLE HDWLE+NBI+pCLE HDWLE+pCLE HDWLE+NBI
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 101 101 101 101 101 101
Overall Number of Units Analyzed
Type of Units Analyzed: Biopsy sites
874 874 874 874 874 874
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of lesions
Sensitivity
34.2
(25.7 to 42.7)
41.7
(32.8 to 50.5)
62.5
(53.8 to 71.2)
75.8
(68.2 to 83.5)
68.3
(60.0 to 76.7)
45.0
(36.1 to 53.9)
Specificity
92.7
(90.8 to 94.6)
90.5
(88.4 to 92.5)
92.7
(90.8 to 94.6)
84.2
(81.6 to 86.8)
87.8
(85.5 to 90.1)
88.2
(85.9 to 90.5)
Time Frame Acutely during the procedure - within the day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description NBI-pCLE or pCLE-NBI
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/122 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/122 (0.00%) 
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: Christophe Bailleul
Organization: Mauna Kea Technologies
Phone: + 33 1 70 08 09 74
EMail: christopheb@maunakeatech.com
Layout table for additonal information
Responsible Party: Mauna Kea Technologies
ClinicalTrials.gov Identifier: NCT00795184    
Other Study ID Numbers: MKT-2008-BE-01
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: June 4, 2012
Results First Posted: May 3, 2016
Last Update Posted: May 3, 2016