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Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

NCT02552017 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1772

Last updated 2015-09-16

No results posted yet for this study

Summary

The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Conditions

  • Colorectal Neoplasms
  • Colonic Polyps
  • Adenoma

Interventions

DEVICE

Endocuff Vision

Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).

Sponsors & Collaborators

  • South Tyneside and Sunderland NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Colin Rees, MBBS, FRCP · South Tyneside and Sunderland NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02552017 on ClinicalTrials.gov