Treatment for fecal incontinence using a silicone implant
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
This study is testing a silicone implant to see if it can help adults with fecal incontinence who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | A.M.I. Agency for Medical Innovations GmbH Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 6 sites (Vienna and 5 other locations) |
| Trial ID | NCT05708612 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the safety and effectiveness of a silicone implant, SimplyFI, designed to treat fecal incontinence in patients who have not responded to standard conservative therapies. The study will involve surgical candidates aged 18 to 85 who have experienced fecal incontinence for at least six months. Participants will be monitored for improvements in their condition following the implantation of the device. The study will also assess the device's performance and any associated risks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who have failed standard conservative treatments for fecal incontinence and are surgical candidates.
Not a fit: Patients with significant chronic defecatory motility disorders or those currently experiencing rectal or vaginal prolapse may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from fecal incontinence.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using implants for fecal incontinence treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna and 5 other locations
- Göttlicher Heiland Krankenhaus — Vienna, Austria (Recruiting)
- Medical University Vienna — Vienna, Austria (Recruiting)
- Klinikum Bielefeld Rosenhöhe — Bielefeld, Germany (Recruiting)
- MVZ Wiesbaden / KD Helios Klinik — Wiesbaden, Germany (Withdrawn)
- Hospital Ruber Internacional — Madrid, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Stefan Riss, Prof. PD Dr. — Medical University Vienna
- Study coordinator: A.M.I. Agency for Medical Innovations (Clinical Affairs)
- Email: ca@ami.at
- Phone: +43 5522 90505-0
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.