A 4-arm Clinical Trial of Fuse®, EndoCuff™, EndoRings™ and Standard Colonoscopy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-12-31

Brief Summary

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Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure

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Detailed Description

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Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.

Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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FUSE® Colonoscopy

A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy

Group Type ACTIVE_COMPARATOR

FUSE® Colonoscopy

Intervention Type DEVICE

colonoscopy performed with the FUSE® (full spectrum endoscopy) system

Colonoscopy with EndoCuff™

An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope

Group Type ACTIVE_COMPARATOR

Colonoscopy with EndoCuff™

Intervention Type DEVICE

colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope

Colonoscopy with EndoRings™

An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope

Group Type ACTIVE_COMPARATOR

Colonoscopy with EndoRings™

Intervention Type DEVICE

colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Standard Colonoscopy

A standard colonoscope will be used to complete the procedure

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type DEVICE

Current standard of care colonoscopy

Interventions

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Colonoscopy with EndoCuff™

colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope

Intervention Type DEVICE

FUSE® Colonoscopy

colonoscopy performed with the FUSE® (full spectrum endoscopy) system

Intervention Type DEVICE

Colonoscopy with EndoRings™

colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope

Intervention Type DEVICE

Standard Colonoscopy

Current standard of care colonoscopy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Screening or Surveillance Colonoscopy

Exclusion Criteria

* Personal history of Colorectal cancer or Inflammatory bowel disease
* Surgical resection of the colon or known colonic stricture
* Personal or family history of Polyposis syndromes or Lynch syndrome
* Referral for incomplete colonoscopy or known therapeutic polyp clearance
* Severe diverticular disease
* Referral for a positive hemoccult test in the past 6 months
* Known coagulopathy
* Inability to provide informed consent

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes