Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
- Conditions
- Fecal Incontinence
- Interventions
- Procedure: Medical Device (SimplyFI)
- Registration Number
- NCT05708612
- Lead Sponsor
- A.M.I. Agency for Medical Innovations GmbH
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Implantation of SimplyFI Medical Device (SimplyFI) Long-term non-active implant
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.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
Trial Locations
- Locations (6)
Göttlicher Heiland Krankenhaus
🇦🇹Vienna, Austria
Medical University Vienna
🇦🇹Vienna, Austria
Klinikum Bielefeld Rosenhöhe
🇩🇪Bielefeld, Germany
MVZ Wiesbaden / KD Helios Klinik
🇩🇪Wiesbaden, Germany
Hospital Ruber Internacional
🇪🇸Madrid, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain