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

NCT03436004 | Completed DMC

• 1 other identifier: ENDOCOLES
• Study Type: interventional
• Target: 1,453
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Colorectal Cancer; Adenoma Colon

Keywords

Colonoscopy; Adenoma; Adenoma detection rate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

Colonoscopy with specific device with CE marking (Endocuff Vision)

Device: Colonoscopy with specific device (Endocuff Vision)

Active Comparator

ACTIVE COMPARATOR

Colonoscopy with standard device of the center

Device: Colonoscopy

Interventions

Colonoscopy DEVICE

Patients undergoing screening colonoscopy

Active Comparator

Colonoscopy with specific device (Endocuff Vision) DEVICE

Patients undergoing screening colonoscopy using the Endocuff Vision device

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (8)

Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Department of Gastroenterology, Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Department of Gastroenterology, Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Department of Gastroenterology, Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Location

Department of Gastroenterology, Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Department of Gastroenterology, Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Department of Gastroenterology, Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon

Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Alberto Herreros de Tejada, MD, PhD

  Puerta de Hierro University Hospital

  PRINCIPAL INVESTIGATOR

• Aurora Burgos, MD

  La Paz University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Concealed assignation
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Multicenter prospective trial with medical device

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 19, 2018
• Study Start: May 18, 2018
• Primary Completion: April 16, 2019
• Study Completion: June 4, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

ES (8)