Clinical trial NCT02785783: Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection
Official title: Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasia
Intestinal Neoplasms
Digestive Neoplasms
Digestive System Disease
Intestinal Disease
Gastrointestinal Disease
Gastrointestinal Neoplasm
Keywords: EndoRings™
Lead sponsor: Portsmouth Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Portsmouth
First posted: 2016-05-30
Enrollment: 563
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of polyps per patient
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Portsmouth University Hospital
state: Hampshire
Study officials:
affiliation: Portsmouth University Hospital
name: Pradeep Bhandari, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1111/j.1572-0241.2006.00390.x.
citation: 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.