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Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection (Erings™)

Primary Purpose

Colorectal Neoplasia, Intestinal Neoplasms, Digestive Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Standard colonoscopy
EndoRings™
Sponsored by
Portsmouth Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Neoplasia focused on measuring EndoRings™

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Portsmouth University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard colonoscopy

EndoRings™

Arm Description

A standard colonoscope will be used to complete the procedure

An EndoRings™ device will be placed at the distal end of a standard colonoscope

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 25, 2016
Last Updated
January 31, 2019
Sponsor
Portsmouth Hospitals NHS Trust
Collaborators
University of Portsmouth
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1. Study Identification

Unique Protocol Identification Number
NCT02785783
Brief Title
Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection
Acronym
Erings™
Official Title
Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
August 7, 2018 (Actual)
Study Completion Date
August 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Portsmouth Hospitals NHS Trust
Collaborators
University of Portsmouth

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasia, Intestinal Neoplasms, Digestive Neoplasms, Digestive System Disease, Intestinal Disease, Gastrointestinal Disease, Gastrointestinal Neoplasm
Keywords
EndoRings™

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
563 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard colonoscopy
Arm Type
Active Comparator
Arm Description
A standard colonoscope will be used to complete the procedure
Arm Title
EndoRings™
Arm Type
Active Comparator
Arm Description
An EndoRings™ device will be placed at the distal end of a standard colonoscope
Intervention Type
Device
Intervention Name(s)
Standard colonoscopy
Other Intervention Name(s)
Current standard of care colonoscopy
Intervention Type
Device
Intervention Name(s)
EndoRings™
Intervention Description
Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
Primary Outcome Measure Information:
Title
Number of polyps per patient
Description
To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.
Time Frame
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pradeep Bhandari, MD
Organizational Affiliation
Portsmouth University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portsmouth University Hospital
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO63LY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16454841
Citation
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.
Results Reference
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PubMed Identifier
26220283
Citation
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.
Results Reference
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Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection

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