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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Adenoma Colon
• Interventions: Device: Colonoscopy with specific device (Endocuff Vision); Device: Colonoscopy

• Registration Number: NCT03436004
• Lead Sponsor: Dr. Alberto Herreros de Tejada Echanojáuregui

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Study Start: 2018-05-18
• Primary Completion: 2019-04-16
• Study Completion: 2019-06-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1453

Inclusion Criteria

All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Colonoscopy with specific device (Endocuff Vision)	Colonoscopy with specific device with CE marking (Endocuff Vision)
Active Comparator	Colonoscopy	Colonoscopy with standard device of the center

Primary Outcome Measures

Name	Time	Method
Mean adenoma per procedure (MAP)	1 day	Mean of adenoma detected by patient
Adenoma detection rate (ADR)	1 day	Number of adenoma detected by colonoscopy

Secondary Outcome Measures

Name	Time	Method
Total number of serrated lesions with or without detected dysplasia by colonoscopy	1 day
Total number of adenomas detected by colonoscopy	1 day
Total number of advanced adenomas detected by colonoscopy	1 day

Trial Locations

Locations (8)

Department of Gastroenterology, Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Department of Gastroenterology, Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda; 🇪🇸 Majadahonda, Madrid, Spain

Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon; 🇪🇸 Madrid, Spain

Department of Gastroenterology, Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Department of Gastroenterology, Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Department of Gastroenterology, Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Department of Gastroenterology, Hospital Universitario La Princesa; 🇪🇸 Madrid, Spain