Trials / Completed
CompletedNCT02785783
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 563 (actual)
- Sponsor
- Portsmouth Hospitals NHS Trust · Other Government
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Colorectal Neoplasia
- Intestinal Neoplasms
- Digestive Neoplasms
- Digestive System Disease
- Intestinal Disease
- Gastrointestinal Disease
- Gastrointestinal Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Standard colonoscopy | |
| DEVICE | EndoRings™ | Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope |
Timeline
- Start date
- 2016-05-13
- Primary completion
- 2018-08-07
- Completion
- 2018-08-07
- First posted
- 2016-05-30
- Last updated
- 2019-02-04
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02785783. Inclusion in this directory is not an endorsement.