Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 563
- Locations
- 1
- Primary Endpoint
- Number of polyps per patient
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptomatic patients referred for colonoscopy age ≥
- •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
Arms & Interventions
Standard colonoscopy
A standard colonoscope will be used to complete the procedure
Intervention: Standard colonoscopy (Device)
EndoRings™
An EndoRings™ device will be placed at the distal end of a standard colonoscope
Intervention: EndoRings™ (Device)
Outcomes
Primary Outcomes
Number of polyps per patient
Time Frame: 14 months
To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.
Secondary Outcomes
No secondary outcomes reported