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

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:

  1. 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,
  2. FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation,
  3. Consent of participation signed,
  4. Affiliation to a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria:

  1. Non-optimal preparation (boston score <7 or segment <2),
  2. Adenomatous polyposis, familial or assimilated (juvenile, etc.),
  3. Pregnant or likely to be pregnant (without effective contraception) or breastfeeding,
  4. Patient in emergency or deprived of liberty or placed under the authority of a tutor,
  5. 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.

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

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.

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