Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy

March 15, 2021 updated by: Maria Fragaki, Venizelio General Hospital

Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. In order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (ADR) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. Since 2012, a new accessory device (Endocuff; ARC Medical Design, Leeds, UK), which is mounted on the tip of the colonoscope has been introduced to the market. The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. Use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal.

The aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of Endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (CRC) screening/surveillance and symptomatic patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Τhe study is a single center cohort study. Venizeleio General Hospital is a tertiary hospital and the population that will be selected would be residents of the island of Crete.

Description

Inclusion Criteria:

  • (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years.

Exclusion Criteria:

  • (i) age below 50 years; (ii) the presence of significant comorbidities (American Society of Anesthesiologists [ASA] score III or IV); (iv) recent abdominal surgery; (iv) inflammatory bowel disease; (v) colectomy; (vi) polyposis syndrome; (vii) the presence of acute, severe colitis or a known colonic stricture (viii) boston scale bowel preparation ≥6.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with polyps and adenomas
The inclusion criteria are: (i) CRC screening; (ii) post-polypectomy surveillance; (iii) diagnostic assessment (anemia, lower gastrointestinal bleeding, abdominal pain, recent change in bowel habits); and (iv) age over 50 years.
Device: endocuff
The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
of Endocuff-assisted colonoscopy adenoma and polyp miss rate
Time Frame: up to 21 days after the colonoscopy
The primary outcome is the measurement of Endocuff-assisted colonoscopy adenoma and polyp miss rates, overall and in the proximal colon.
up to 21 days after the colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Venizelio General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (ACTUAL)

March 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VenizelioGH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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