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

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenoma Colon
• Intervention / Treatment: Device: Colonoscopy with specific device (Endocuff Vision); Device: Colonoscopy

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 Type: Interventional
• Enrollment (Actual): 1453
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28006
    • Department of Gastroenterology, Hospital Universitario La Princesa
  • Madrid, Spain, 28007
    • Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28034
    • Department of Gastroenterology, Hospital Universitario Ramón y Cajal
  • Madrid, Spain, 28040
    • Department of Gastroenterology, Hospital Clínico San Carlos
  • Madrid, Spain, 28041
    • Department of Gastroenterology, Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Department of Gastroenterology, Hospital Universitario La Paz
  • Madrid, Spain, 28922
    • Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Dr. Alberto Herreros de Tejada Echanojáuregui
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): April 16, 2019
• Study Completion (Actual): June 4, 2019

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenoma; Adenoma detection rate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: ENDOCOLES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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