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

D

Dr. Alberto Herreros de Tejada Echanojáuregui

Status

Completed

Conditions

Adenoma Colon
Colorectal Cancer

Treatments

Device: Colonoscopy
Device: Colonoscopy with specific device (Endocuff Vision)

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT03436004
ENDOCOLES

Details and patient eligibility

About

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

Full 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.

Enrollment

1,453 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,453 participants in 2 patient groups

Experimental
Experimental group
Description:
Colonoscopy with specific device with CE marking (Endocuff Vision)
Treatment:
Device: Colonoscopy with specific device (Endocuff Vision)
Active Comparator
Active Comparator group
Description:
Colonoscopy with standard device of the center
Treatment:
Device: Colonoscopy

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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