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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1453 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2019-06-04

Brief Summary

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

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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.

Conditions

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Colorectal Cancer Adenoma Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Multicenter prospective trial with medical device

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Concealed assignation

Study Groups

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Experimental

Colonoscopy with specific device with CE marking (Endocuff Vision)

Group Type EXPERIMENTAL

Colonoscopy with specific device (Endocuff Vision)

Intervention Type DEVICE

Patients undergoing screening colonoscopy using the Endocuff Vision device

Active Comparator

Colonoscopy with standard device of the center

Group Type ACTIVE_COMPARATOR

Colonoscopy

Intervention Type DEVICE

Patients undergoing screening colonoscopy

Interventions

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Colonoscopy

Patients undergoing screening colonoscopy

Intervention Type DEVICE

Colonoscopy with specific device (Endocuff Vision)

Patients undergoing screening colonoscopy using the Endocuff Vision device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients with positive immunologic fecal occult blood test (IFOBT) for population screening.
2. Patients invited to an opportunistic screening colonoscopy or included regional population screening program.
3. Patients with a family history of CRC and indication of screening colonoscopy.
4. Patients with follow-up colonoscopy indication by personal history of adenomas.

Exclusion Criteria

1. Patients with absolute contraindications for colonoscopy (suspicion of intestinal obstruction or perforation, acute diverticulitis suspected or confirmed 6 weeks before the colonoscopy, etc).
2. Symptomatic patients with indication of diagnostic colonoscopy.
3. Patients with a personal history of CRC.
4. Patients with a personal history of chronic inflammatory bowel disease (IBD).
5. Patients with a known personal history of hereditary CRC syndrome:

I. No polyposis (Lynch syndrome). II. Polypic.
6. Patients with suspected attenuated polyposis (\> 20 adenomas) with genetic diagnosis not defined.
7. Patients with total or partial colic resection.
8. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year
9. Pregnant or breastfeeding mothers.
10. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent.
11. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No