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Completed

NCT Number: NCT03436004

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients must be adults (≥18 years), give their consent for endoscopic exploration, for the study and meet following inclusion criteria:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Colonoscopy

Device

Patients undergoing screening colonoscopy

Colonoscopy with specific device (Endocuff Vision)

Device

Patients undergoing screening colonoscopy using the Endocuff Vision device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr. Alberto Herreros de Tejada Echanojáuregui

Other

Collaborators

  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

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

Acronym: ENDOCOLES

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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