Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas

Study Overview
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Brief Summary
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Evaluation of colonoscopy with a specific device for the detection of adenomas: Multicenter, prospective and randomized study

Detailed Description
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Given the discrepancy in the results of the published studies, the main objective of the present study would be to evaluate, through a multicentric design and with a sufficiently large sample of patients, if there are relevant differences in the ADR and in the MAP between the colonoscopy performed with a device specific (Endocuff visionTM) versus standard colonoscopy. Secondarily, the number of adenomas, the number of advanced adenomas and the number of serrated lesions in both groups.

Official Title
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Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study

Conditions
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Colorectal Cancer, Adenoma Colon

Intervention / Treatment
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* Device: Colonoscopy
* Device: Colonoscopy with specific device (Endocuff Vision)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria: Patients with positive immunologic fecal occult blood test (IFOBT) for population screening. Patients invited to an opportunistic screening colonoscopy or included regional population screening program. Patients with a family history of CRC and indication of screening colonoscopy. Patients with follow-up colonoscopy indication by personal history of adenomas. Exclusion Criteria: Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc). Symptomatic patients with indication of diagnostic colonoscopy. Patients with a personal history of CRC. Patients with a personal history of chronic inflammatory bowel disease (IBD). Patients with a known personal history of hereditary CRC syndrome: I. No polyposis (Lynch syndrome). II. Polypic. Patients with suspected attenuated polyposis (> 20 adenomas) with genetic diagnosis not defined. Patients with total or partial colic resection. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year Pregnant or breastfeeding mothers. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent. Patients with any serious and uncontrolled medical, psychological, psychiatric, geographic or social problem that could interfere with the participation of the patient in the study or not allow an adequate follow-up and adherence with the protocol and evaluation of the results of the study.

Ages Eligible for Study
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Minimum Age: 18 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: Randomized Multicenter prospective trial with medical device
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Colonoscopy with specific device with CE marking (Endocuff Vision) | Device: Colonoscopy with specific device (Endocuff Vision)<br>* Patients undergoing screening colonoscopy using the Endocuff Vision device<br>|
| Active Comparator: Active Comparator<br>Colonoscopy with standard device of the center | Device: Colonoscopy<br>* Patients undergoing screening colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (ADR) | Number of adenoma detected by colonoscopy | 1 day | 
| Mean adenoma per procedure (MAP) | Mean of adenoma detected by patient | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of adenomas detected by colonoscopy |  | 1 day | 
| Total number of advanced adenomas detected by colonoscopy |  | 1 day | 
| Total number of serrated lesions with or without detected dysplasia by colonoscopy |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Adenoma, Adenoma detection rate