Detection in Tandem Endocuff Cap Trial

Overview

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

Full Title of Study: “Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Investigator)
  • Study Primary Completion Date: April 2017

Interventions

  • Device: Endocuff
    • It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
  • Device: cap assisted colonoscopy (CAC)
    • cap assisted colonoscopy (CAC)

Arms, Groups and Cohorts

  • Active Comparator: Endocuff assisted colonoscopy
    • Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.
  • Placebo Comparator: Cap assisted colonoscopy
    • Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Mean adenoma per procedure
    • Time Frame: 1 day
    • Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.
  • Endocuff or cap exchange
    • Time Frame: 1 day
    • Number of times Cap or Endocuff are removed to complete the procedure
  • Ceacal intubation and withdrawal time
    • Time Frame: 1 day
    • Comparison of caecal intubation and withdrawal time
  • 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
  • Comfort score
    • Time Frame: 1 day
    • Comparison of patient comfort score between CAC and EAC

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • London North West Healthcare NHS Trust
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Brian P Saunders, MD, Principal Investigator, St Mark’s Hospital, Northwest London Hospitals NHS Trust

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