Outcomes of Disposable Distal Attachment Device (Endocuff and Transparent Plastic Cap) Assisted Colonoscopy

NCT ID: NCT02504411

Last Updated: 2018-08-13

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-02-15

Brief Summary

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The purpose of the study is to compare the efficacy of device assisted colonoscopy (DAC) with standard colonoscopy (SC) in detecting adenomas in a randomized fashion.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Device Assisted Colonoscopy

Device assisted colonoscopy (DAC) is a technique of attaching disposable devices like "Endocuff" or "Transparent cap" at tip of colonoscope to improve mucosal visualization and stability.

Group Type EXPERIMENTAL

Device Assisted Colonoscopy

Intervention Type DEVICE

This will be similar to the standard colonoscopy except the endocuff device will be used.

Standard Colonoscopy

Standard colonoscopy is the endoscopic examination of the large bowel and the distal part of the small bowel with a camera on a flexible tube passed through the anus.

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type DEVICE

No endocuff device will be used on the study participants undergoing standard colonoscopy.

Interventions

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Device Assisted Colonoscopy

This will be similar to the standard colonoscopy except the endocuff device will be used.

Intervention Type DEVICE

Standard Colonoscopy

No endocuff device will be used on the study participants undergoing standard colonoscopy.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing first screening colonoscopy
2. Patients undergoing subsequent surveillance colonoscopies with known history of prior colon polyps detected on prior screening colonoscopies.
3. Ability to provide informed consent.

Exclusion Criteria

1. Previous surgical resection of any part of the colon
2. history of colon cancer
3. history of inflammatory bowel disease
4. use of antiplatelet agents or anti-coagulants that precluded removal of polyps
5. Poor general condition
6. History of polyposis syndrome or hereditary nonpolyposis colorectal cancer
7. Inability to give informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Nirav C Thosani

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nirav Thosani, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-12-0587

Identifier Type: -

Identifier Source: org_study_id

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