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Endocuff Adenoma Detection Rate Pilot Study

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ClinicalTrials.gov Identifier: NCT01761097
Recruitment Status : Unknown
Verified January 2013 by Rob Mead, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : January 4, 2013
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
Rob Mead, Cambridge University Hospitals NHS Foundation Trust

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
Colorectal Adenoma Colorectal Cancer Device: Endocuff attachment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Endocuff assisted colonoscopy
Endocuff attachment
Device: Endocuff attachment
Endocuff
Other Name: ARC endocuff
Placebo Comparator: Control standard colonoscopy
Standard colonoscopy



Primary Outcome Measures :
  1. Proportion of patients with adenomas and cancers detected [ Time Frame: immediate ]

Secondary Outcome Measures :
  1. Caecal intubation time [ Time Frame: Immediate ]

Other Outcome Measures:
  1. Caecal intubation rate [ Time Frame: immediate ]
  2. Polyp detection rate [ Time Frame: immediate ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013

Keywords provided by Rob Mead, 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