Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection (Erings™)

Portsmouth Hospitals NHS Trust

Status: Completed

Conditions: Digestive Neoplasms; Gastrointestinal Neoplasm; Gastrointestinal Disease; Intestinal Disease; Intestinal Neoplasms; Digestive System Disease; Colorectal Neoplasia

Treatments: Device: EndoRings™; Device: Standard colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02785783

PHT/2015/101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 563 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

563 participants in 2 patient groups

Standard colonoscopy

Active Comparator group

Description:

A standard colonoscope will be used to complete the procedure

Treatment:

Device: Standard colonoscopy

EndoRings™

Active Comparator group

Description:

An EndoRings™ device will be placed at the distal end of a standard colonoscope

Treatment:

Device: EndoRings™