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

A.M.I. Agency for Medical Innovations

Status: Enrolling

Conditions: Fecal Incontinence

Treatments: Procedure: Medical Device (SimplyFI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05708612

CIV-AT-23-01-041926 (Other Identifier)

CI-48-001

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Implantation of SimplyFI

Experimental group

Description:

Long-term non-active implant

Treatment:

Procedure: Medical Device (SimplyFI)