NCT03418662

EndoRings Colonoscopy vs Standard Colonoscopy

A Randomized Trial Comparing the Adenoma Detection Rates Between EndoRings Colonoscopy (EC) and Standard Colonoscopy (SC).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The study aims to compare the results between a standard colonoscopy to a colonoscopy with an attachment on the distal end of the colonoscope.

Detailed description

This will be a prospective, randomized controlled study. Subjects referred for screening or surveillance colonoscopy will be prospectively enrolled. This study aims to compare the adenoma detection rates between EndoRings colonoscopy (EC) and Standard colonoscopy (SC). It is assumed that the proportion of patients with at least one adenoma would be 25% with SC and 35% with EC.

Conditions

• Colorectal Adenoma
• Colorectal Polyp
• Colon Cancer

Interventions

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

Timeline

• Start date: 2018-01-19
• Primary completion: 2018-09-13
• Completion: 2018-09-13
• First posted: 2018-02-01
• Last updated: 2019-09-20
• Results posted: 2019-09-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study