Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.

NCT ID: NCT02374515

Last Updated: 2016-06-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-03-31

Brief Summary

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This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.

Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.

Detailed Description

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Conditions

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Adenomatous Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Endocuff assisted Colonoscopy

Endocuff assisted Colonoscopy

Group Type ACTIVE_COMPARATOR

EndoCuff-assisted colonoscopy

Intervention Type DEVICE

Adenoma detection rate

Standard Colonoscopy

Standard colonoscopy

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type DEVICE

Interventions

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EndoCuff-assisted colonoscopy

Adenoma detection rate

Intervention Type DEVICE

Standard Colonoscopy

Intervention Type DEVICE

Other Intervention Names

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EC-assisted colonoscopy

Eligibility Criteria

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Inclusion Criteria

* Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion Criteria

* Pregnancy
* age\<18 years
* age \> 80 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Naples

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Domenico De Palma

Full Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giovanni D. De Palma, MD

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

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University of Naples Federico II

Naples, , Italy

Site Status

Countries

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Italy

Other Identifiers

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230/14

Identifier Type: -

Identifier Source: org_study_id

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