Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

NCT03961893 | Completed FDA Device

• 2 other identifiers: G-EYE-ADR-IPC 2016-0232018-A03292-53
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenoma

Keywords

colonoscopy; g-eye; adenomas

Outcome Measures

Primary Outcomes (1)

• 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

  Colonoscopy time

Secondary Outcomes (6)

• Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device)

  Colonoscopy time

• Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female

  Colonoscopy time

• Rate of complications

  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

  Colonoscopy time

• Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup

  Colonoscopy time

Study Arms (2)

Arm A: Standard colonoscopy then colonoscopy with G-EYE

EXPERIMENTAL

Arm A: Standard colonoscopy then colonoscopy with G-EYE

Device: standard colonoscope first and G-EYE

Arm B: G-EYE colonoscopy then standard colonoscopy

EXPERIMENTAL

Arm B: G-EYE colonoscopy then standard colonoscopy

Device: G-EYE first and standard colonoscope

Interventions

G-EYE first and standard colonoscope DEVICE

Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy

Arm B: G-EYE colonoscopy then standard colonoscopy

standard colonoscope first and G-EYE DEVICE

Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)

Arm A: Standard colonoscopy then colonoscopy with G-EYE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Location

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Jean-Philippe RATONE, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-phase, two-stage, randomized phase II study

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: January 21, 2020
• Primary Completion: May 19, 2023
• Study Completion: June 19, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)