Clincosm LogoSign in Get a demo

Endocuff Adenoma Detection Rate Pilot Study

Sponsor
Cambridge University Hospitals NHS Foundation Trust (Other)
Overall Status
Unknown status
CT.gov ID
NCT01761097
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
11
Duration (Months)
27.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon.

The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.

The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.

Condition or Disease Intervention/Treatment Phase
  • Device: Endocuff attachment
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
A Pilot Study to Assess the Role for Endocuff© Assisted Colonoscopy in the Detection of Colonic Cancer and Polyps
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Oct 1, 2013
Anticipated Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Endocuff assisted colonoscopy

Endocuff attachment

Device: Endocuff attachment
Endocuff
Other Names:
  • ARC endocuff

    		•
    Placebo Comparator: Control standard colonoscopy

    Standard colonoscopy

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with adenomas and cancers detected [immediate]

    Secondary Outcome Measures

    1. Caecal intubation time [Immediate]

    Other Outcome Measures

    1. Caecal intubation rate [immediate]

    2. Polyp detection rate [immediate]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.

    • Ability to understand the nature and requirements of the study and to provide written informed consent.

    Exclusion Criteria:

    • Contraindication to undergo standard colonoscopy.

    • Severe active colitis.

    • Known colonic stricture

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Addenbrooke's Hospital Cambridge United Kingdom CB2OQQ

    Sponsors and Collaborators

    • Cambridge University Hospitals NHS Foundation Trust

    Investigators

    • Principal Investigator: Ewen Cameron, MBBS, Cambridge University Hospitals NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rob Mead, Dr. R.J.Mead, Cambridge University Hospitals NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT01761097
    Other Study ID Numbers:
    • AO92673
    First Posted:
    Jan 4, 2013
    Last Update Posted:
    Jan 8, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Rob Mead, Dr. R.J.Mead, Cambridge University Hospitals NHS Foundation Trust
    Adenoma, polyp, colonoscopy.
    Additional relevant MeSH terms:
    Adenoma

    Study Results

    No Results Posted as of Jan 8, 2013