- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03961893
Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas (G-EYE-ADR)
June 22, 2023 updated by: Institut Paoli-Calmettes
Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas.
This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy.
The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope.
Thus, the detection rate of adenomas would be improved by this better vision.
The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
164
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bouches Du Rhone
-
Marseille, Bouches Du Rhone, France, 13009
- Institut Paoli Calmettes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control,
- FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
- Consent of participation signed,
- Affiliation to a social security scheme, or beneficiary of such a scheme.
Exclusion Criteria:
- Non-optimal preparation (boston score <7 or segment <2),
- Adenomatous polyposis, familial or assimilated (juvenile, etc.),
- Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
- Patient in emergency or deprived of liberty or placed under the authority of a tutor,
- Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: Standard colonoscopy then colonoscopy with G-EYE
|
Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)
|
Experimental: Arm B: G-EYE colonoscopy then standard colonoscopy
|
Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Time Frame: Colonoscopy time
|
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections
|
Colonoscopy time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Time Frame: Colonoscopy time
|
Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections
|
Colonoscopy time
|
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female
Time Frame: Colonoscopy time
|
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female
|
Colonoscopy time
|
Rate of complications
Time Frame: Colonoscopy time and 1 month after
|
Global and for each arm
|
Colonoscopy time and 1 month after
|
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup
Time Frame: Colonoscopy time
|
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup
|
Colonoscopy time
|
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup
Time Frame: Colonoscopy time
|
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup
|
Colonoscopy time
|
G-EYE assistance for endoscope stabilization
Time Frame: Colonoscopy time
|
Yes or no
|
Colonoscopy time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Philippe RATONE, MD, Institut Paoli-Calmettes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2020
Primary Completion (Actual)
May 19, 2023
Study Completion (Actual)
June 19, 2023
Study Registration Dates
First Submitted
May 21, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 23, 2019
Study Record Updates
Last Update Posted (Actual)
June 23, 2023
Last Update Submitted That Met QC Criteria
June 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G-EYE-ADR-IPC 2016-023
- 2018-A03292-53 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Adenoma
-
National Cancer Institute (NCI)Active, not recruitingColorectal Adenoma | Colorectal Adenoma With Severe Dysplasia | Colorectal Tubulovillous AdenomaUnited States, Puerto Rico
-
University of DundeeCompletedColorectal Cancer | Colorectal AdenomaUnited Kingdom
-
Shandong UniversityCompletedColorectal Cancer | Colorectal AdenomaChina
-
Docbot, Inc.RecruitingColorectal Adenoma | Colorectal Adenocarcinoma | Colorectal Polyp | Colorectal SSAUnited States
-
Hospital Sirio-LibanesCompletedColorectal Cancer | Colonoscopy | Adenoma Detection Rate | Adenoma Colon | Colorectal Polyp | Sessile Serrated Adenoma | Quality IndicatorBrazil
-
University Hospitals Coventry and Warwickshire...University of Leeds; University of Manchester; University of WarwickRecruitingColorectal Cancer | Colorectal Disorders | Colorectal Adenoma | Colorectal PolypUnited Kingdom
-
Martin-Luther-Universität Halle-WittenbergUniversity of Ulm; Deutsche Krebshilfe e.V., Bonn (Germany); KKS NetzwerkCompletedColorectal Serrated Adenomas | Colorectal Tubular Adenomas | Colorectal Villous Adenomas | Colorectal Tubulovillous AdenomasGermany
-
Changhai HospitalUnknownColorectal Adenoma | Colorectal PolypChina
-
Chinese University of Hong KongRecruitingColorectal Adenoma | Colorectal Polyp | Advanced AdenomaHong Kong
-
Indiana UniversityCompletedColorectal Cancer | Colorectal Adenoma | Colorectal PolypUnited States
Clinical Trials on standard colonoscope first and G-EYE
-
Dr. Horst Schmidt Klinik GmbHCompletedColorectal Cancer | AdenomaUnited States, Germany
-
Smart Medical Systems Ltd.FujifilmRecruitingColorectal Cancer | AdenomaGermany
-
Dr. Horst Schmidt Klinik GmbHCompletedAdenoma | Colo-rectal CancerGermany
-
Smart Medical Systems Ltd.CompletedColorectal Cancer | Adenoma | PolypsUnited States, Netherlands, Israel, United Kingdom, India, Germany, Denmark, Italy
-
Smart Medical Systems Ltd.UnknownColorectal Cancer | Adenoma | PolypsIsrael
-
Smart Medical Systems Ltd.CompletedColorectal Cancer | AdenomaGermany
-
Smart Medical Systems Ltd.CompletedColorectal Cancer | Adenoma | PolypIsrael, Germany
-
Dr. Horst Schmidt Klinik GmbHRecruiting
-
Dr. Horst Schmidt Klinik GmbHRecruiting
-
Evidence Based Cataract Study GroupUnknown