Back to resultsPanoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas (G-EYE-ADR)
Primary Purpose
Colorectal Adenoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
G-EYE first and standard colonoscope
standard colonoscope first and G-EYE
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Adenoma focused on measuring colonoscopy, g-eye, adenomas
Eligibility Criteria
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.
Sites / Locations
- Institut Paoli Calmettes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A: Standard colonoscopy then colonoscopy with G-EYE
Arm B: G-EYE colonoscopy then standard colonoscopy
Arm Description
Arm A: Standard colonoscopy then colonoscopy with G-EYE
Arm B: G-EYE colonoscopy then standard colonoscopy
Outcomes
Primary Outcome Measures
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections
Secondary Outcome Measures
Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female
Rate of complications
Global and for each arm
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup
G-EYE assistance for endoscope stabilization
Yes or no
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03961893
Brief Title
Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Acronym
G-EYE-ADR
Official Title
Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
June 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenoma
Keywords
colonoscopy, g-eye, adenomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-phase, two-stage, randomized phase II study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Standard colonoscopy then colonoscopy with G-EYE
Arm Type
Experimental
Arm Description
Arm A: Standard colonoscopy then colonoscopy with G-EYE
Arm Title
Arm B: G-EYE colonoscopy then standard colonoscopy
Arm Type
Experimental
Arm Description
Arm B: G-EYE colonoscopy then standard colonoscopy
Intervention Type
Device
Intervention Name(s)
G-EYE first and standard colonoscope
Intervention Description
Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy
Intervention Type
Device
Intervention Name(s)
standard colonoscope first and G-EYE
Intervention Description
Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)
Primary Outcome Measure Information:
Title
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Description
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections
Time Frame
Colonoscopy time
Secondary Outcome Measure Information:
Title
Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)
Description
Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections
Time Frame
Colonoscopy time
Title
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female
Description
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female
Time Frame
Colonoscopy time
Title
Rate of complications
Description
Global and for each arm
Time Frame
Colonoscopy time and 1 month after
Title
Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup
Description
Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup
Time Frame
Colonoscopy time
Title
Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup
Description
Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup
Time Frame
Colonoscopy time
Title
G-EYE assistance for endoscope stabilization
Description
Yes or no
Time Frame
Colonoscopy time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe RATONE, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
State/Province
Bouches Du Rhone
ZIP/Postal Code
13009
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas
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