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

• Sponsor: Dr. Alberto Herreros de Tejada Echanojáuregui (Other)
• Overall Status: Completed
• CT.gov ID: NCT03436004
• Collaborator: Spanish Clinical Research Network - SCReN (Other)
• Enrollment: 1,453
• Locations: 8
• Arms: 2
• Actual Duration (Months): 12.6
• Patients Per Site: 181.6
• Patients Per Site Per Month: 14.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Adenoma Colon	Device: Colonoscopy; Device: Colonoscopy with specific device (Endocuff Vision)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1453 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Multicenter prospective trial with medical deviceRandomized Multicenter prospective trial with medical device
• Masking: None (Open Label)
• Masking Description: Concealed assignation
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Colonoscopy With a Specific Device for the Detection of Adenomas: Multicenter, Prospective and Randomized Study
• Actual Study Start Date: May 18, 2018
• Actual Primary Completion Date: Apr 16, 2019
• Actual Study Completion Date: Jun 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Colonoscopy with specific device with CE marking (Endocuff Vision)	Device: Colonoscopy with specific device (Endocuff Vision); Patients undergoing screening colonoscopy using the Endocuff Vision device
Active Comparator: Active Comparator Colonoscopy with standard device of the center	Device: Colonoscopy; Patients undergoing screening colonoscopy

Outcome Measures

Primary Outcome Measures

1. Adenoma detection rate (ADR) [1 day]

   Number of adenoma detected by colonoscopy

2. Mean adenoma per procedure (MAP) [1 day]

   Mean of adenoma detected by patient

Secondary Outcome Measures

1. Total number of adenomas detected by colonoscopy [1 day]

2. Total number of advanced adenomas detected by colonoscopy [1 day]

3. Total number of serrated lesions with or without detected dysplasia by colonoscopy [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. No polyposis (Lynch syndrome). II. Polypic.

1. Patients with suspected attenuated polyposis (> 20 adenomas) with genetic diagnosis not defined.

2. Patients with total or partial colic resection.

3. Complete colonoscopy with an adequate preparation (total Boston ≥6 with at least score ≥2 per segment) in a period of less than a year

4. Pregnant or breastfeeding mothers.

5. Patients who have expressed their wish not to participate or who do not have the ability to understand and / or sign informed consent.

6. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid	Spain	28222
2	Department of Gastroenterology, Hospital Universitario La Princesa	Madrid		Spain	28006
3	Department of Gastroenterology, Hospital General Universitario Gregorio Marañón	Madrid		Spain	28007
4	Department of Gastroenterology, Hospital Universitario Ramón y Cajal	Madrid		Spain	28034
5	Department of Gastroenterology, Hospital Clínico San Carlos	Madrid		Spain	28040
6	Department of Gastroenterology, Hospital Universitario 12 de Octubre	Madrid		Spain	28041
7	Department of Gastroenterology, Hospital Universitario La Paz	Madrid		Spain	28046
8	Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon	Madrid		Spain	28922

Sponsors and Collaborators

• Dr. Alberto Herreros de Tejada Echanojáuregui
• Spanish Clinical Research Network - SCReN

Investigators

• Principal Investigator: Alberto Herreros de Tejada, MD, PhD, Puerta de Hierro University Hospital
• Principal Investigator: Aurora Burgos, MD, La Paz University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Alberto Herreros de Tejada Echanojáuregui, Principal Investigator, Puerta de Hierro University Hospital
• ClinicalTrials.gov Identifier: NCT03436004
• Other Study ID Numbers: ENDOCOLES
• First Posted: Feb 19, 2018
• Last Update Posted: Aug 22, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Dr. Alberto Herreros de Tejada Echanojáuregui, Principal Investigator, Puerta de Hierro University Hospital: Colonoscopy; Adenoma; Adenoma detection rate
• Additional relevant MeSH terms: Adenoma

Study Results

No Results Posted as of Aug 22, 2019