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Completed

NCT Number: NCT02331836

Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy

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

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Key information

Conditions

Colorectal Polyps Colorectal Adenomas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Muenster, Münster, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Colonoscopy independent from indication
  • Age ≥ 18
  • Patient is able to provide informed consent for the procedure

Exclusion criteria

  • Inflammatory Bowel Disease stenosis
  • Pregnant of nursing patient
  • Acute diverticulitis
  • Active Inflammatory Bowel Disease
  • Age ≤ 18
  • Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)

Treatment and study plan

Arc Endocuff (AEC 110, 120, 130, 140)

Device

cap

Device

Olympus Disposable distal attachment 15mm diameter, 4mm depth

Standard colonoscope

Device

Primary outcomes

  1. Adenoma detection rate

    Time frame: 1 year

    Proportion of patients having at least one adenoma

  2. Polyp detection rate

    Time frame: 1 year

    Proportion of patients having at least one adenoma

Secondary outcomes

  1. Bowel preparation result

    Time frame: one day

  2. Coecum intubation rate

    Time frame: one year

  3. Ileum intubation rate

    Time frame: one year

  4. Coecum intubation time

    Time frame: one day

  5. withdrawal time

    Time frame: one day

  6. mucosal laceration

    Time frame: one day

  7. severe bleeding

    Time frame: one day

  8. perforation

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Helios Albert-Schweitzer-Klinik Northeim

Other

Registry information

Official study title

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

Acronym: EC-Cap-SC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2015
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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