Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

Colorectal Adenoma Clinical Trial

— G-EYE-ADR  

Official title:

Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03961893
• Other study ID #: G-EYE-ADR-IPC 2016-023
• Secondary ID: 2018-A03292-53
• Status: Completed
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: June 19, 2023

Study information

• Verified date: May 2023
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: June 19, 2023
• Est. primary completion date: May 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma

Intervention

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

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Colonoscopy time
Secondary	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	Colonoscopy time
Secondary	Rate of complications	Global and for each arm	Colonoscopy time and 1 month after
Secondary	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	Colonoscopy time
Secondary	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	Colonoscopy time
Secondary	G-EYE assistance for endoscope stabilization	Yes or no	Colonoscopy time