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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fecal Incontinence
• Intervention / Treatment: Procedure: Medical Device (SimplyFI)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University Vienna
  • Vienna, Austria
    • Göttlicher Heiland Krankenhaus
• Germany
  • Bielefeld, Germany
    • Klinikum Bielefeld Rosenhöhe
• Spain
  • Madrid, Spain
    • Hospital Ruber Internacional
  • Madrid, Spain
    • Hospital Universitario Ramón y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both male and female subjects
• Age ≥ 18 years, <85 years
• Subject has failed standard conservative therapy for fecal incontinence (at least 6 months)
• Subject is a surgical candidate
• Subject is willing and able to cooperate with follow-up examinations
• Subject has been informed of the study procedures and the treatment and has signed an informed consent form and provided authorization to use and disclose information for research purposes.

Exclusion Criteria:

• Treatment with another investigational drug or investigational device
• Unable to understand study requirements or is unable to comply with follow-up schedule
• Contraindicated according to the instruction for use of the device
• Pregnancy or nursing, or plans to become pregnant
• History of significant obstructed defecation or other significant chronic defecatory motility disorders
• Current, external full thickness rectal prolapse or vaginal prolapse
• Inflammatory Bowel Disease
• Irritable Bowel Syndrome
• Systemic disease as source of FI (scleroderma, neurologic disorders, Crohn's)
• Active pelvic infection
• Chronic diarrhea
• Medical history of anal, rectal, or colon cancer
• Prior anterior resection of the rectum
• Medical history of pelvic radiation therapy
• Significant scarring of the recto-vaginal septum, a permanent implant in the rectovaginal septum, or a history of recto-vaginal fistula
• Previous anorectal posterior compartment surgery
• History of complex anal fistula

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implantation of SimplyFI; Long-term non-active implant	Procedure: Medical Device (SimplyFI); Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety-related complications and adverse events	The primary endpoint is safety-related complications and adverse events during follow-up until 12 months after surgery.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs))	The secondary endpoint is to evaluate the change of fecal incontinence assessed by validated scores (changes from baseline to 1 week, 1 months, 3 months, 6 months) until 12 months after surgery. Fecal Incontinence Quality of Life scale (all subscale scores 1-4). Scales range from 1 to 5, with a 1 indicating a lower functional status of quality of life. Scale scores are the average (mean) response to all items in the scale.	12 months
Quality of Life (St. Mark's incontinence score (SMIS))	The secondary endpoint is to evaluate the change of Quality of Life assessed by validated scores (changes from baseline to 1 week, 1 months, 3 months, 6 months) until 12 months after surgery. St. Marks incontinence score contains 7 questions, and a higher total score means a worse outcome	12 months

Collaborators and Investigators

• Sponsor: A.M.I. Agency for Medical Innovations GmbH
• Investigators: Principal Investigator: Stefan Riss, Prof. PD Dr., Medical University Vienna; Principal Investigator: José Manuel Devesa Múgica, Dr., Hospital Ruber Internacional

Publications and helpful links

General Publications

• Dawoud C, Devesa JM, Lohnert M, Vicente R, Metwalli SA, Riss S. Artificial sphincter with a new silicone band for treating faecal incontinence: IDEAL 2b prospective multicentre trial. BJS Open. 2025 Sep 8;9(5):zraf112. doi: 10.1093/bjsopen/zraf112.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Implant; Surgical Treatment
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Fecal Incontinence; Equipment and Supplies
• Other Study ID Numbers: CI-48-001; CIV-AT-23-01-041926 (Other Identifier: EUDAMED CIV-ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No