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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

Keywords

  • Colonoscopy
  • Adenoma
  • Adenoma detection rate
03

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's enrollment of 1,453 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Dr. Alberto Herreros de Tejada Echanojáuregui is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 .
  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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

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
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Apr 2019, 10 months.

Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's 10 months is below that.

Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 19, 2018
StartActual
May 18, 2018
Primary completionActual
Apr 16, 2019
CompletionActual
Jun 4, 2019
Last update
Aug 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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.

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Discussion

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