Usefulness of Endocuff in the Adenoma Detection Rate. Comparative Study

NCT ID: NCT02387593

Last Updated: 2015-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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Colorectal cancer (CRC) is one of the leading causes of cancer death worldwide. The cumulative risk of developing CRC is about 6% lifelong.

The benefit of screening colonoscopy depends on the detection and removal of all adenomas, however, some of these may be difficult to detect.

The "endocuff" (EC) is a polymer sleeve which joins the tip of the colonoscope to improve the image viewing of the mucosa during colonoscopy procedure.

There is insufficient evidence of the usefulness of endocuf

Detailed Description

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All patients requiring colonoscopy for screening and who agree to participate in the study will be included and randomized them to make an standard colonoscopy or colonoscopy with endocuff, for randomization system will be used in balanced blocks of 4, created on the page randomization.com.

Conditions

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Colorectal Canceer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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colonoscopy with endocuff

To the usual colonoscopy will place a endocuff at the tip of the colonoscope

Group Type EXPERIMENTAL

ENDOCUFF

Intervention Type DEVICE

One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline

standard colonoscopy without endocuff

Routine colonoscopy without endocuff

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ENDOCUFF

One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy adult patients,
* Aged 18,
* Who would come to colonoscopy for colon cancer screening without prior colonoscopy studies

Exclusion Criteria

* Boston colonic preparation \<5 points
* Suspected Lynch syndrome or familial adenomatous polyposis (FAP)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rafael Barreto Zúñiga

Attached to the Department of Endoscopy Medical Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rafael Rafael, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Endoscopy

Locations

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Rafael Barreto

México, Tlalpan, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Rafael RB Barreto Zúñiga, MD

Role: CONTACT

0155- 54870900 ext. 2150

Rafael Rafael, MD

Role: CONTACT

0155-54870900 ext. 2150

Facility Contacts

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Rafael Barreto, MD

Role: primary

54870900 ext. 2150

Other Identifiers

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END-1302-14/15-1

Identifier Type: -

Identifier Source: org_study_id

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