EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

Overview

The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.

The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.

The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.

Full Title of Study: “A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 2014

Interventions

  • Device: EndoCuff-assisted colonoscopy
    • EC-assisted colonoscopy
  • Device: Standard colonoscopy
    • Standard colonoscopy

Arms, Groups and Cohorts

  • Active Comparator: Endocuff-assisted colonoscopy
    • Endocuff-assisted colonoscopy
  • Active Comparator: Standard colonoscopy
    • Standard Colonoscopy

Clinical Trial Outcome Measures

Primary Measures

  • adenoma detection rate
    • Time Frame: 25 minutes
    • completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.

Secondary Measures

  • polyp detection rate
    • Time Frame: 1 Week
  • number of LGIN and HGIN adenomas detected
    • Time Frame: one week
    • LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia
  • polyp distribution
    • Time Frame: 25 minutes
  • procedure time
    • Time Frame: 25 Minutes
  • withdrawal time
    • Time Frame: 10 Minutes
    • without intervention time due to polypectomy
  • ileum intubation rate
    • Time Frame: 10 minutes
  • total colonoscopy rate
    • Time Frame: 25 minutes
  • adverse events
    • Time Frame: 25 minutes
    • perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy

Participating in This Clinical Trial

Inclusion Criteria

indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent

Exclusion Criteria

  • pregnancy
  • age<18 years
  • known colonic strictures
  • chronic inflammatory bowel disease
  • active inflammation
  • s/p colonic resection

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helios Albert-Schweitzer-Klinik Northeim
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tobias Meister, PD Dr. med. – Helios Albert-Schweitzer-Klinik Northeim
  • Overall Official(s)
    • Tobias Meister, M.D., Principal Investigator, Helios Albert-Schweitzer-Hospital

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