Clinical Trial: Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study

Brief Summary: Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

Detailed Summary: The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.
Sponsor: Helios Albert-Schweitzer-Klinik Northeim

Current Primary Outcome:

  • Adenoma detection rate [ Time Frame: 1 year ]
    Proportion of patients having at least one adenoma
  • Polyp detection rate [ Time Frame: 1 year ]
    Proportion of patients having at least one adenoma


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Bowel preparation result [ Time Frame: one day ]
  • Coecum intubation rate [ Time Frame: one year ]
  • Ileum intubation rate [ Time Frame: one year ]
  • Coecum intubation time [ Time Frame: one day ]
  • withdrawal time [ Time Frame: one day ]
  • mucosal laceration [ Time Frame: one day ]
  • severe bleeding [ Time Frame: one day ]
  • perforation [ Time Frame: one day ]


Original Secondary Outcome: Same as current

Information By: Helios Albert-Schweitzer-Klinik Northeim

Dates:
Date Received: January 2, 2015
Date Started: February 2015
Date Completion: December 2018
Last Updated: February 28, 2017
Last Verified: February 2017