Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Indiana University

Status: Completed

Conditions: Colorectal Adenoma; Colorectal Polyp; Colorectal Cancer

Treatments: Device: AmplifEYE device; Device: Endocuff Vision device

Study type: Interventional

Funder types: Other

Identifiers

NCT03560128

1802193017

Details and patient eligibility

About

The study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

Full description

This will be a prospective, randomized controlled study. Subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. This study aims to compare the number of adenomas detected per colonoscopy (APC) between an Endocuff colonoscopy and an AmplifEYE colonoscopy.

It is estimated that the Endocuff Vision will result in an APC of 2.3. The investigators consider that a clinically acceptable ADR for the Medivators device would be within 20% of this value or 1.5.

Enrollment: 634 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 40 years of age or older
• Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
• Able to provide written informed consent

Exclusion criteria

• Active Inflammatory Bowel Disease
• Prior resection of the colon
• Referred for resection of a polyp identified by another physician
• Referred for a previous incomplete colonoscopy

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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634 participants in 2 patient groups

Endocuff Vision Arm

Experimental group

Description:

Colonoscopy with Endocuff Vision device attached to the distal end of the scope.

Treatment:

Device: Endocuff Vision device

AmplifEYE Arm

Experimental group

Description:

Colonoscopy with AmplifEYE device attached to the distal end of the scope.

Treatment:

Device: AmplifEYE device