Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

Completed

• Conditions: Colorectal Adenoma

• Registration Number: NCT02859870
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-18
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-09
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• Age >18 years
• Diagnostic colonoscopy

Exclusion Criteria

• Colorectal cancer
• Colic surgery
• Preparation of average or poor quality
• Rectal polyp of hyperplastic type <2 mm

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy	1 day	Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection

Secondary Outcome Measures

Name	Time	Method
Toxicity	1 day	Serious adverse events (perforation, uncontrolled bleeding)

Trial Locations

Locations (1)

Institut Paoli Cakmettes; 🇫🇷 Marseille, Bouches du Rhône, France