CClinicalTrials.gg
CompletedNCT03436004ENDOCOLESUpdated Aug 22, 2019

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

An interventional study of Colonoscopy and Colonoscopy with specific device (Endocuff Vision) in Colorectal Cancer and Adenoma Colon, sponsored by Dr. Alberto Herreros de Tejada Echanojáuregui. Completed at 8 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-22.

Sponsored by Dr. Alberto Herreros de Tejada Echanojáuregui · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,453
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Colorectal Cancer
  • Adenoma Colon

Browse trials for

Keywords

  • Colonoscopy
  • Adenoma
  • Adenoma detection rate
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,453 participants (actual)

Study arms

  • 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

  • DeviceColonoscopy

    Patients undergoing screening colonoscopy

  • DeviceColonoscopy with specific device (Endocuff Vision)

    Patients undergoing screening colonoscopy using the Endocuff Vision device

05

What researchers measure

Primary outcomes

  1. Adenoma detection rate (ADR)

    Number of adenoma detected by colonoscopy

    Time frame: 1 day

  2. Mean adenoma per procedure (MAP)

    Mean of adenoma detected by patient

    Time frame: 1 day

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

06

Study locations

8 sites
  • Department of Gastroenterology, Hospital Universitario Puerta de Hierro - Majadahonda
    Majadahonda, Madrid 28222, Spain
  • Department of Gastroenterology, Hospital Universitario La Princesa
    Madrid, 28006, Spain
  • Department of Gastroenterology, Hospital General Universitario Gregorio Marañón
    Madrid, 28007, Spain
  • Department of Gastroenterology, Hospital Universitario Ramón y Cajal
    Madrid, 28034, Spain
  • Department of Gastroenterology, Hospital Clínico San Carlos
    Madrid, 28040, Spain
  • Department of Gastroenterology, Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Department of Gastroenterology, Hospital Universitario La Paz
    Madrid, 28046, Spain
  • Department of Gastroenterology, Hospital Universitario Fundacion Alcorcon
    Madrid, 28922, Spain
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03436004
Lead sponsor
Dr. Alberto Herreros de Tejada Echanojáuregui
Collaborators
Spanish Clinical Research Network - SCReN
Responsible party
Dr. Alberto Herreros de Tejada Echanojáuregui (Principal Investigator, Puerta de Hierro University Hospital) — Sponsor-investigator
First posted
Feb 19, 2018
Start date
May 18, 2018
Primary completion
Apr 16, 2019
Completion
Jun 4, 2019
Last update
Aug 22, 2019

Study contacts

Alberto Herreros de Tejada, MD, PhD
principal investigator · Puerta de Hierro University Hospital
Aurora Burgos, MD
principal investigator · La Paz University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion