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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03436004
Recruitment Status : Completed
First Posted : February 16, 2018
Last Update Posted : August 22, 2019
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 Device: Colonoscopy with specific device (Endocuff Vision) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1453 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
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : June 4, 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 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




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


Locations
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Spain
Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain, 28222
Department of Gastroenterology, Hospital Universitario La Princesa
Madrid, Spain, 28006
Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Department of Gastroenterology, Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Department of Gastroenterology, Hospital Clínico San Carlos
Madrid, Spain, 28040
Department of Gastroenterology, Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Department of Gastroenterology, Hospital Universitario La Paz
Madrid, Spain, 28046
Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
Madrid, Spain, 28922
Sponsors and Collaborators
Dr. Alberto Herreros de Tejada Echanojáuregui
Spanish Clinical Research Network - CAIBER
Investigators
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Principal Investigator: Alberto Herreros de Tejada, MD, PhD Puerta de Hierro University Hospital
Principal Investigator: Aurora Burgos, MD La Paz University Hospital

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Responsible Party: Dr. Alberto Herreros de Tejada Echanojáuregui, Principal Investigator, 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: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Adenoma
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type