NCT03961893

Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	G-EYE first and standard colonoscope	Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy
DEVICE	standard colonoscope first and G-EYE	Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)

Timeline

• Start date: 2020-01-21
• Primary completion: 2023-05-19
• Completion: 2023-06-19
• First posted: 2019-05-23
• Last updated: 2023-06-23

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated device study