Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

Gastrointestinal Disease Clinical Trial

— Erings™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785783
• Other study ID #: PHT/2015/101
• Status: Completed
• Phase: N/A
• Start date: May 13, 2016
• Est. completion date: August 7, 2018

Study information

• Verified date: January 2019
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: August 7, 2018
• Est. primary completion date: August 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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

Intervention

Device:
• Standard colonoscopy

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

Locations

Country	Name	City	State
United Kingdom	Portsmouth University Hospital	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust	University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Dik VK, Gralnek IM, Segol O, Suissa A, Belderbos TD, Moons LM, Segev M, Domanov S, Rex DK, Siersema PD. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy--results of the CLEVER study. Endoscopy. 2015 Dec;47(12):1151-8. doi: 10.1055/s-0034-1392421. Epub 2015 Jul 28. — View Citation

van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of polyps per patient	To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.	14 months