Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Standard colonoscopy
* Device: EndoRings™


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard colonoscopy<br>A standard colonoscope will be used to complete the procedure | Device: Standard colonoscopy<br> <br> * Other names: Current standard of care colonoscopy;|
| Active Comparator: EndoRings™<br>An EndoRings™ device will be placed at the distal end of a standard colonoscope | Device: EndoRings™<br>* Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EndoRings™