Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

Not Applicable

Completed

• Conditions: Colorectal Neoplasia; Intestinal Neoplasms; Digestive Neoplasms; Gastrointestinal Disease; Digestive System Disease; Intestinal Disease; Gastrointestinal Neoplasm
• Interventions: Device: EndoRings™; Device: Standard colonoscopy

• Registration Number: NCT02785783
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-05-13
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-27
• Study First Posted: 2016-05-30
• Primary Completion: 2018-08-07
• Study Completion: 2018-08-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 563

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EndoRings™	EndoRings™	An EndoRings™ device will be placed at the distal end of a standard colonoscope
Standard colonoscopy	Standard colonoscopy	A standard colonoscope will be used to complete the procedure

Primary Outcome Measures

Name	Time	Method
Number of polyps per patient	14 months	To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.

Trial Locations

Locations (1)

Portsmouth University Hospital; 🇬🇧 Portsmouth, Hampshire, United Kingdom