NCT04280393

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 stabilizing the colonoscope. Likewise, the impact of the use of ENDOCUFF VISION® on the average number of adenomas detected per patient (MAPP) as well as serrated adenomas (MASPP), the total time of the endoscopic procedure, cecal intubation and the safety of its use will be estimated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
822

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

February 14, 2020

Last Update Submit

November 17, 2022

Conditions

Cancer Colorectal

Keywords

adenomacolonoscopyendocuffscreening

Outcome Measures

Primary Outcomes (2)

  • polyps detection rate per patient

    Rate of polyps detected

    immediately after the procedure

  • adenoma detection rate per patient

    Rate of Adenoma detected

    immediately after the procedure

Secondary Outcomes (7)

  • differences in the mean of adenomas detected by patient

    immediately after the procedure

  • Serrated adenoma rate detected by patient

    immediately after the procedure

  • Cancer lesion detection rate comparing Endocuff Colonoscopy and Standard Colonoscopy.

    immediately after the procedure

  • Cecal intubation rate and time to reach the cecum

    immediately after the procedure

  • Total time of the procedure

    immediately after the procedure

  • +2 more secondary outcomes

Study Arms (2)

Endocuff

EXPERIMENTAL

Colonoscopy procedure with the use of endocuff

Device: Colonoscopy procedure with endocuff

Control

ACTIVE COMPARATOR

Standard Colonoscopy procedure

Device: Colonoscopy procedure with endocuff

Interventions

Colonoscopy procedure with endocuffDEVICE

Colonoscopy procedure with the use of ENDOCUFF VISION

ControlEndocuff

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Provincial de Castellon

Castellon, Castellon, 12002, Spain

Location

MeSH Terms

Conditions

Colonic NeoplasmsAdenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2020

First Posted

February 21, 2020

Study Start

February 10, 2020

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)