Endocuff Adenoma Detection Rate Pilot Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Cambridge University Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Rob Mead, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01761097
First received: January 3, 2013
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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 Intervention
Colorectal Adenoma
Colorectal Cancer
Device: Endocuff attachment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess the Role for Endocuff© Assisted Colonoscopy in the Detection of Colonic Cancer and Polyps

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Proportion of patients with adenomas and cancers detected [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caecal intubation time [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Caecal intubation rate [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Polyp detection rate [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endocuff assisted colonoscopy
Endocuff attachment
Device: Endocuff attachment
Endocuff
Other Name: ARC endocuff
Placebo Comparator: Control standard colonoscopy
Standard colonoscopy

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761097

Locations
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2OQQ
Contact: Ewen Cameron, MBBS    01223 348718    ewen.cameron@addenbrookes.nhs.uk   
Principal Investigator: Rob Mead, MBBS         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Ewen Cameron, MBBS Cambridge University Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Rob Mead, Dr. R.J.Mead, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01761097     History of Changes
Other Study ID Numbers: AO92673
Study First Received: January 3, 2013
Last Updated: January 4, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Adenoma, polyp, colonoscopy.

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014