NCT03361917

Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Prospective Randomized Controlled Trial of High-Definition White-light Colonoscopy Versus High-Definition White-light Colonoscopy With Endocuff Vision for Endpoints of Procedural Times

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).

Detailed description

For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.

Conditions

• Colorectal Polyp
• Colorectal Adenoma
• Colon Cancer

Interventions

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

Timeline

• Start date: 2017-12-11
• Primary completion: 2018-04-18
• Completion: 2018-04-18
• First posted: 2017-12-05
• Last updated: 2019-08-06
• Results posted: 2019-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study