NCT03898778

Effects of an Anal Insert Device in Fecal Incontinence

Effects of the Minnesota Medical Technologies Anal Insert Device in Fecal Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Minnesota Medical Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to test the effects of an inserted anal device on fecal incontinence (accidental bowel leakage) in patients who have persistent symptoms despite other conservative therapy.

Detailed description

This is a prospective, open label study designed to evaluate the efficacy, safety, and tolerability of the Minnesota Medical Technologies Anal Insert Device in participants with Fecal Incontinence (FI).

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Minnesota Medical Technologies Anal Insert Device	Non-sterile soft, flexible, liquid-filled anal insert either 10 mm size or 13 mm size, meant for single use only

Timeline

• Start date: 2019-05-16
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2019-04-02
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study