Status:

COMPLETED

Effectiveness and Safety of the Colonoscopy Assisted by Endocuff vs. Standard in the Colorectal Cancer Screening

Lead Sponsor:

Hospital Provincial de Castellon

Conditions:

Cancer Colorectal

Eligibility:

All Genders

50-70 years

Phase:

NA

Brief Summary

The hypothesis of the present study is to demonstrate that ENDOCUFF VISION® increases the detection rate of adenomas thanks to the improved visibility produced by the retraction of the folds and stabi...

Detailed Description

The main objective of the colorectal cancer screening program (CRC) is the detection of the greatest number of precursor lesions of neoplasms as well as cancerous lesions established in the general po...

Eligibility Criteria

Inclusion

  • A) Patients between the ages of 50 and 70 referred for a colonoscopy within the colorectal cancer screening program.
  • B) With the ability to provide informed consent

Exclusion

  • History of inflammatory bowel disease
  • History or suspected obstruction or intestinal pseudo-obstruction located in the colon
  • History of colon cancer or polyposic syndromes
  • History of colonic stenosis
  • History of severe diverticular segments in some region of the colon
  • Subjects unable to provide informed consent
  • Subjects under treatment with clopidogrel, warfarin, acenocoumarol or other new generation anticoagulants that have not discontinued treatment in accordance with the provisions of these procedures
  • Pregnants females
  • Subjects who are going to undergo a therapeutic or surveillance endoscopy for follow-up of injuries diagnosed in previous procedures
  • Subjects whose baseline status does not allow the completion of the questionnaires necessary for the evaluation of the study objectives.
  • History of previous colonic surgery except for appendectomy
  • Any medical, psychological, psychiatric, geographic or social problem that is important and uncontrolled that may interfere with the patient's participation in the study or that does not allow adequate follow-up and adherence to the protocol and evaluation of the study results.

Key Trial Info

Start Date :

February 10 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2021

Estimated Enrollment :

822 Patients enrolled

Trial Details

Trial ID

NCT04280393

Start Date

February 10 2020

End Date

November 30 2021

Last Update

November 21 2022

Active Locations (1)

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1

Hospital Provincial de Castellon

Castellon, Castellon, Spain, 12002