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
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|
|Intervention Model:||Parallel Assignment|
|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|
Active Comparator: Endocuff assisted colonoscopy
Device: Endocuff attachment
Other Name: ARC endocuff
Placebo Comparator: Control standard colonoscopy
- Proportion of patients with adenomas and cancers detected [ Time Frame: immediate ]
- Caecal intubation time [ Time Frame: Immediate ]
- Caecal intubation rate [ Time Frame: immediate ]
- Polyp detection rate [ Time Frame: immediate ]
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
|Cambridge, United Kingdom, CB2OQQ|
|Contact: Ewen Cameron, MBBS 01223 348718 firstname.lastname@example.org|
|Principal Investigator: Rob Mead, MBBS|
|Principal Investigator:||Ewen Cameron, MBBS||Cambridge University Hospitals NHS Foundation Trust|