Detection in Tandem Endocuff Cap Trial

Study Overview
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Brief Summary
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A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy

Official Title
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Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas

Conditions
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Colonic Neoplasms, Adenomas Serrated, Colo-rectal Cancer, Colon Adenoma

Intervention / Treatment
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* Device: Endocuff
* Device: cap assisted colonoscopy (CAC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and over Referral for surveillance, or diagnostic colonoscopy Ability to give informed consent Exclusion Criteria: Absolute contraindications to colonoscopy Established or suspicion of large bowel obstruction or pseudo-obstruction Known colon cancer or polyposis syndromes Known colonic strictures Known severe diverticular segment (that is likely to impede colonoscope passage) Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) Patients lacking capacity to give informed consent Pregnancy Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endocuff assisted colonoscopy<br>Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy. | Device: Endocuff<br>* It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination<br>|
| Placebo Comparator: Cap assisted colonoscopy<br>Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy. | Device: cap assisted colonoscopy (CAC)<br>* cap assisted colonoscopy (CAC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma miss rate | Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean adenoma per procedure | Difference in mean adenomas detected per procedure (MAP) between EAC and CAC. | 1 day | 
| Endocuff or cap exchange | Number of times Cap or Endocuff are removed to complete the procedure | 1 day | 
| Ceacal intubation and withdrawal time | Comparison of caecal intubation and withdrawal time | 1 day | 
| miss rate of advanced polyps | Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC | 1 day | 
| Comfort score | Comparison of patient comfort score between CAC and EAC | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonic adenoma, serrated polyps, caecal intubation time, withdrawal time, polyp miss rate