BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Summary

This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.

Conditions

• Colorectal Neoplasms
• Colonic Polyp
• Adenoma
• Neoplasia GI
• Digestive System Neoplasms
• Intestinal Neoplasms
• Neoplasms, Glandular and Epithelial
• Digestive Disease
• Intestinal Diseases
• Colonic Diseases
• Rectal Diseases
• Intestinal Polyps
• Polyps
• Pathological Conditions, Anatomical

Interventions

DEVICE

Endocuff Vision

The EndocuffTM (ARC Medical Design Ltd and Diagmed, UK) is a device (CE marked in UK) made of a soft plastic material with a unique dynamic shape. Endocuff Vision™ is placed snugly around the colonoscope tip prior to insertion. It does not project beyond the tip of the scope, providing an unrestricted view. It helps anchor the scope tip against the bowel wall to provide a stable platform of access. The soft, elastic projections are pushed back (recoiled) towards the scope shaft during insertion but evert during withdrawal to hold colon folds away from the field of view.

Sponsors & Collaborators

• ARC Medical Design Ltd

  collaborator UNKNOWN

• Norgine

  collaborator INDUSTRY

• South Tyneside and Sunderland NHS Foundation Trust

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

61 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-02-14

Primary Completion

2018-02-13

Completion

2018-02-13

Countries

• United Kingdom

Study Locations