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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: Institut Paoli-Calmettes

Current Primary Outcome:

  • Efficacy [ Time Frame: 1 day ]
    Cecal intubation rate
  • Efficacy [ Time Frame: 1 day ]
    Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection


Original Primary Outcome: Same as current

Current Secondary Outcome: Toxicity [ Time Frame: 1 day ]

Serious adverse events (perforation, uncontrolled bleeding)


Original Secondary Outcome: Same as current

Information By: Institut Paoli-Calmettes

Dates:
Date Received: August 2, 2016
Date Started: March 2015
Date Completion:
Last Updated: August 4, 2016
Last Verified: July 2016