Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

NCT ID: NCT03961893

Last Updated: 2023-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2023-06-19

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Standard colonoscopy then colonoscopy with G-EYE

Arm A: Standard colonoscopy then colonoscopy with G-EYE

Group Type: EXPERIMENTAL

standard colonoscope first and G-EYE

Intervention Type: DEVICE

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

Arm B: G-EYE colonoscopy then standard colonoscopy

Arm B: G-EYE colonoscopy then standard colonoscopy

Group Type: EXPERIMENTAL

G-EYE first and standard colonoscope

Intervention Type: DEVICE

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

Interventions

G-EYE first and standard colonoscope

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

Intervention Type: DEVICE

standard colonoscope first and G-EYE

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Paoli-Calmettes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe RATONE, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, France

Countries

France

Other Identifiers

2018-A03292-53

Identifier Type: OTHER

Identifier Source: secondary_id

G-EYE-ADR-IPC 2016-023

Identifier Type: -

Identifier Source: org_study_id