Comparisons of Endo-Wing-assisted Colonoscopy Versus Standard Colonoscopy in Improving Adenoma De… (NCT06859125) | Clinical Trial Compass
CompletedNot Applicable
Comparisons of Endo-Wing-assisted Colonoscopy Versus Standard Colonoscopy in Improving Adenoma Detection Rate in Symptomatic Patients Suspected of Colorectal Cancer
Malaysia192 participantsStarted 2019-09-01
Plain-language summary
Colorectal cancer (CRC) is the most common cancer in Malaysia. Colonoscopy is the gold standard for bowel cancer screening and the diagnosis of bowel pathology. Adenoma detection rate (ADR) is an important intraprocedural quality indicator, where endoscopists with ADR below 20% had ratios for the development of cancer more than 10 times higher than endoscopists with ADR more than 20%. A low ADR can be due to inferior visualization, especially at locations proximal to colonic folds and flexures.
Endo-Wing™ (Shangxian Minimal Invasive Inc, China) is a medical-grade soft silicone rubber device that is attached to the end of a colonoscope. It has 6 soft wing-like projections that are bendable and pliable, which gives a superior visualization directly from its action of flattening the colonic folds and maintaining the central view of the colonoscope during withdrawal. This can improve the endoscopist's ADR. The purpose of this study is to compare the adenoma detection rate between standard colonoscopy and Endo-Wing™ assisted colonoscopy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients who will be undergoing screening, diagnostic, surveillance and therapeutic colonoscopy at the HCTM Endoscopic Unit
Exclusion Criteria:
* Patients with colonic strictures,
* Patients with active colitis,
* Patients with known polyposis syndrome,
* Patients with known severe diverticulosis,
* Patients with known right hemicolectomy,
* Patients with colostomy/ileostomy and
* Patients with poor bowel preparation (Boston Bowel Preparation Scale (BBPS) score of 3 and below ).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adenoma Detection Rate (ADR)
Timeframe: From enrollment through study completion, an average of 8 months.
Trial details
NCT IDNCT06859125
SponsorUniversiti Kebangsaan Malaysia Medical Centre