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OpenTrials
Completed

NCT Number: NCT02034929

EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection

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.

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Key information

Conditions

Polyp Adenoma Cancer Colonic Diseases Colonic Neoplasms Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Göttingen, Göttingen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

EndoCuff-assisted colonoscopy

Device

EC-assisted colonoscopy

Standard Colonoscopy

Device

Standard colonoscopy

Primary outcomes

  1. 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 outcomes

  1. polyp detection rate

    Time frame: 1 Week

  2. number of LGIN and HGIN adenomas detected

    Time frame: one week

    LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia

  3. polyp distribution

    Time frame: 25 minutes

  4. procedure time

    Time frame: 25 Minutes

  5. withdrawal time

    Time frame: 10 Minutes

    without intervention time due to polypectomy

  6. ileum intubation rate

    Time frame: 10 minutes

  7. total colonoscopy rate

    Time frame: 25 minutes

  8. adverse events

    Time frame: 25 minutes

    perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy

Sponsors and collaborators

Lead sponsor

Helios Albert-Schweitzer-Klinik Northeim

Other

Registry information

Official study title

A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 14, 2014
Registry last updated
Mar 7, 2018

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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