NCT03560128

Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy

Comparison of Endocuff Vision to Medivators AmplifEYE for Detection of Precancerous Colorectal Polyps.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 634 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Colorectal Adenoma
• Colorectal Polyp
• Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Endocuff Vision device	Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
DEVICE	AmplifEYE device	Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.

Timeline

• Start date: 2018-04-12
• Primary completion: 2018-12-18
• Completion: 2018-12-18
• First posted: 2018-06-18
• Last updated: 2019-10-08
• Results posted: 2019-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study