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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Procedure: Medical Device (SimplyFI)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Treatment, Implant