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

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ClinicalTrials.gov Identifier: NCT03436004
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Dr. Alberto Herreros de Tejada Echanojáuregui, Puerta de Hierro University Hospital

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 Phase 4

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  (Clinical Trial)
Estimated Enrollment : 1452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: Experimental
Colonoscopy with specific device with CE marking (Endocuff Vision)
Device: Colonoscopy
Patients undergoing screening colonoscopy

Active Comparator: Active Comparator
Colonoscopy with standard device of the center
Device: Colonoscopy
Patients undergoing screening colonoscopy




Primary Outcome Measures :
  1. Adenoma detection rate (ADR) [ Time Frame: 1 day ]
    Number of adenoma detected by colonoscopy

  2. Mean adenoma per procedure (MAP) [ Time Frame: 1 day ]
    Mean of adenoma detected by patient


Secondary Outcome Measures :
  1. Total number of adenomas detected by colonoscopy [ Time Frame: 1 day ]
  2. Total number of advanced adenomas detected by colonoscopy [ Time Frame: 1 day ]
  3. Total number of serrated lesions with or without detected dysplasia by colonoscopy [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436004


Contacts
Contact: Alberto Herreros de Tejada, MD, PhD +34 911 917 909 a_herreros_tejada.phierro@yahoo.com
Contact: Aurora Burgos García, MD burgos.aurora@gmail.com

Locations
Spain
Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Alberto Herreros de Tejada, MD, PhD       a_herreros_tejada.phierro@yahoo.es   
Principal Investigator: Alberto Herreros de Tejada, MD, PhD         
Department of Gastroenterology, Hospital Universitario La Princesa Recruiting
Madrid, Spain, 28006
Contact: Mirella Jiménez, MD       mirella_altea@hotmail.com   
Principal Investigator: Mirella Jiménez, MD         
Department of Gastroenterology, Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Rodrigo Borobia       borobiarodrigo@hotmail.com   
Principal Investigator: Rodrigo Borobia, MD         
Department of Gastroenterology, Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Contact: Beatriz Peñas, MD       beatriz.penyas@gmail.com   
Principal Investigator: Beatriz Peñas, MD         
Department of Gastroenterology, Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Natalia López-Palacios, MD       natalia.lopa@gmail.com)   
Principal Investigator: Natalia López-Palacios, MD         
Department of Gastroenterology, Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Julia Arribas, MD       jantiart@gmail.com   
Principal Investigator: Julia Arribas, MD         
Department of Gastroenterology, Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Aurora Burgos, MD       burgos.aurora@gmail.com   
Principal Investigator: Aurora Burgos, MD         
Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon Recruiting
Madrid, Spain, 28922
Contact: Guillermo Cacho, MD       gcacho@fhalcorcon.es   
Principal Investigator: Guillermo Cacho, MD         
Sponsors and Collaborators
Dr. Alberto Herreros de Tejada Echanojáuregui
Spanish Clinical Research Network - CAIBER
Investigators
Principal Investigator: Alberto Herreros de Tejada, MD, PhD Puerta de Hierro University Hospital
Principal Investigator: Aurora Burgos, MD La Paz University Hospital

Responsible Party: Dr. Alberto Herreros de Tejada Echanojáuregui, MD, PhD, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT03436004     History of Changes
Other Study ID Numbers: ENDOCOLES
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
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, Puerta de Hierro University Hospital:
Colonoscopy
Adenoma
Adenoma detection rate

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
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