Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Portsmouth | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard colonoscopy | Active Comparator | A standard colonoscope will be used to complete the procedure |
|
| EndoRings™ | Active Comparator | An EndoRings™ device will be placed at the distal end of a standard colonoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard colonoscopy | Device |
|
| |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pradeep Bhandari, MD | Portsmouth University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth University Hospital | Portsmouth | Hampshire | PO63LY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16454841 | Background | 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. | |
| 26220283 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EndoRings™ |
| Device |
Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope |
|
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided