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Completed

NCT Number: NCT03254498

Detection in Tandem Endocuff Cap Trial

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

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Key information

Conditions

Colonic Neoplasms Adenomas Serrated Colo-rectal Cancer Colon Adenoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthWest London Hospitals - NOrthwick park hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and over
  • Referral for surveillance, or diagnostic colonoscopy
  • Ability to give informed consent

Exclusion criteria

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

Treatment and study plan

endocuff

Device

It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination

cap assisted colonoscopy (CAC)

Device

cap assisted colonoscopy (CAC)

Primary outcomes

  1. Adenoma miss rate

    Time frame: 1 day

    Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E

Secondary outcomes

  1. Mean adenoma per procedure

    Time frame: 1 day

    Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.

  2. Endocuff or cap exchange

    Time frame: 1 day

    Number of times Cap or Endocuff are removed to complete the procedure

  3. Ceacal intubation and withdrawal time

    Time frame: 1 day

    Comparison of caecal intubation and withdrawal time

  4. 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

  5. Comfort score

    Time frame: 1 day

    Comparison of patient comfort score between CAC and EAC

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study title

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

Acronym: DETECT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 18, 2017
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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