Detection in Tandem Endocuff Cap Trial (DETECT)

August 17, 2017 updated by: London North West Healthcare NHS Trust

Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas

A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United Kingdom
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • NorthWest London Hospitals - NOrthwick park hospital

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years and over
  2. Referral for surveillance, or diagnostic colonoscopy
  3. Ability to give informed consent

Exclusion Criteria:

  1. Absolute contraindications to colonoscopy
  2. Established or suspicion of large bowel obstruction or pseudo-obstruction
  3. Known colon cancer or polyposis syndromes
  4. Known colonic strictures
  5. Known severe diverticular segment (that is likely to impede colonoscope passage)
  6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
  7. Patients lacking capacity to give informed consent
  8. Pregnancy
  9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Endocuff assisted colonoscopy
Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
Device: Endocuff
It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
PLACEBO_COMPARATOR: Cap assisted colonoscopy
Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
Device: cap assisted colonoscopy (CAC)
cap assisted colonoscopy (CAC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma miss rate
Time Frame: 1 day
Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean adenoma per procedure
Time Frame: 1 day
Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.
1 day
Endocuff or cap exchange
Time Frame: 1 day
Number of times Cap or Endocuff are removed to complete the procedure
1 day
Ceacal intubation and withdrawal time
Time Frame: 1 day
Comparison of caecal intubation and withdrawal time
1 day
miss rate of advanced polyps
Time Frame: 1 day
Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC
1 day
Comfort score
Time Frame: 1 day
Comparison of patient comfort score between CAC and EAC
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of surveillance intervals
Time Frame: Once histology is available usually takes 10-14 days
To compare any surveillance interval difference between CAC and EAC
Once histology is available usually takes 10-14 days

Collaborators and Investigators

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

Sponsor

London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: Brian P Saunders, MD, St Mark's Hospital, Northwest London Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 17, 2017

First Posted (ACTUAL)

August 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 17, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD15/061

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.

Clinical Trials on Colonic Neoplasms

Clinical Trials on Endocuff

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe