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

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05708612
• Other study ID #: CI-48-001
• Secondary ID: CIV-AT-23-01-041
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: A.M.I. Agency for Medical Innovations GmbH
• Contact: A.M.I. Agency for Medical Innovations (Clinical Affairs)
• Phone: +43 5522 90505-0
• Email: ca[@]ami.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Procedure:
• Medical Device (SimplyFI)
Implantation a non-active medical device (SimplyFI) for the treatment of chronic fecal incontinence.

Locations

Country	Name	City	State
Austria	Göttlicher Heiland Krankenhaus	Vienna
Austria	Medical University Vienna	Vienna
Germany	Klinikum Bielefeld Rosenhöhe	Bielefeld
Germany	MVZ Wiesbaden / KD Helios Klinik	Wiesbaden
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
A.M.I. Agency for Medical Innovations GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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