MedTrace Logo

Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

NCT05708612 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-20

No results posted yet for this study

Summary

The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.

Conditions

  • Fecal Incontinence

Interventions

PROCEDURE

Medical Device (SimplyFI)

Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.

Sponsors & Collaborators

  • A.M.I. Agency for Medical Innovations GmbH

    lead INDUSTRY

Principal Investigators

  • Stefan Riss, Prof. PD Dr. · Medical University Vienna

  • José Manuel Devesa Múgica, Dr. · Hospital Ruber Internacional

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-04-30
Completion
2026-09-30

Countries

  • Austria
  • Germany
  • Spain

Study Locations

More Related Trials

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 NCT05708612 on ClinicalTrials.gov