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

Sponsor
A.M.I. Agency for Medical Innovations GmbH (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05708612
Collaborator
(none)
36
6
1
30.1
6
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Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Medical Device (SimplyFI)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Safety-related complications and adverse events [12 months]

    The primary endpoint is safety-related complications and adverse events during follow-up until 12 months after surgery.

Secondary Outcome Measures

  1. Cure of fecal incontinence (Fecal Incontinence Quality of Life Scale (FIQLs)) [12 months]

    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.

  2. Quality of Life (St. Mark's incontinence score (SMIS)) [12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Göttlicher Heiland Krankenhaus Vienna Austria
2 Medical University Vienna Vienna Austria
3 Klinikum Bielefeld Rosenhöhe Bielefeld Germany
4 MVZ Wiesbaden / KD Helios Klinik Wiesbaden Germany
5 Hospital Ruber Internacional Madrid Spain
6 Hospital Universitario Ramón y Cajal Madrid Spain

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Stefan Riss, Prof. PD Dr., Medical University Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
A.M.I. Agency for Medical Innovations GmbH
ClinicalTrials.gov Identifier:
NCT05708612
Other Study ID Numbers:
  • CI-48-001
  • CIV-AT-23-01-041926
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 3, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by A.M.I. Agency for Medical Innovations GmbH
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2023