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Effects of an Anal Insert Device in Fecal Incontinence

NCT03898778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-08-22

Study results available
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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.

Conditions

  • Fecal Incontinence

Interventions

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

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Minnesota Medical Technologies

    lead INDUSTRY

Principal Investigators

  • Adil E Bharucha, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2024-02-20
Completion
2024-02-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898778 on ClinicalTrials.gov