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Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02785783
Acronym
Erings™
Enrollment
563
Registered
2016-05-30
Start date
2016-05-13
Completion date
2018-08-07
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasia, Digestive Neoplasms, Digestive System Disease, Gastrointestinal Disease, Gastrointestinal Neoplasm, Intestinal Disease, Intestinal Neoplasms

Keywords

EndoRings™

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.

Interventions

DEVICEStandard colonoscopy
DEVICEEndoRings™

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

Sponsors

University of Portsmouth
CollaboratorOTHER
Portsmouth Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of polyps per patient14 monthsTo assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026