Skip to main content
OpenTrials
Completed

NCT Number: NCT02785783

Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Neoplasia Digestive Neoplasms Digestive System Disease Digestive System Diseases Digestive System Neoplasms Gastrointestinal Disease Gastrointestinal Diseases Gastrointestinal Neoplasm Gastrointestinal Neoplasms Intestinal Disease Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portsmouth University Hospital

Portsmouth, Hampshire, PO63LY, United Kingdom

About this study

Colonoscopy is the gold standard for detection of colorectal neoplasia (polyps and cancers) but it is well known that colonoscopy is associated with a neoplasia miss rate of up to 25%.

One such method of reducing the neoplasia miss rate is cap assisted colonoscopy, where a cap is placed at the distal end of the colonoscope.The theory behind how the cap aids mucosal visualisation is that it depresses and flattens colonic folds, thereby improving visualisation on the proximal sides of folds.

Investigators aim to evaluate the impact of one such cap assisted device: EndoRings™ on polyp detection rates. EndoRings™ has been shown to improve polyp detection rate by 51% compared to 29% for standard colonoscopy in a recent tandem endoscopy study. EndoRings™ has received FDA approval.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Symptomatic patients referred for colonoscopy age ≥ 55.
  • Asymptomatic patients age ≥55 undergoing screening or surveillance for polyps and cancers.

Exclusion criteria

  • History of Inflammatory bowel disease
  • History of Hereditary non polyposis colorectal cancer (HNPCC)
  • Familial adenomatous polyposis syndrome (FAP)
  • Hyperplastic polyposis syndrome
  • Known colonic stricture

Treatment and study plan

Standard Colonoscopy

Device

Other names: Current standard of care colonoscopy

EndoRings™

Device

Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Primary outcomes

  1. Number of polyps per patient

    Time frame: 14 months

    To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Collaborators

  • University of Portsmouth

Registry information

Official study title

Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial

Acronym: Erings™

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 30, 2016
Registry last updated
Feb 4, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.