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NCT05708612 | Recruiting | Fecal Incontinence

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

Condition or disease

Fecal Incontinence

Intervention/treatment

Medical Device (SimplyFI)

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 36 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
Actual Study Start Date : April 1, 2023
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025
Arm Intervention/treatment

Experimental: Implantation of SimplyFI

Long-term non-active implant

Procedure: Medical Device (SimplyFI)
Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Austria,

Divine Savior Hospital

Vienna, Austria,

Recruiting

Austria,

Medical University Vienna

Vienna, Austria,

Recruiting

Germany,

Bielefeld Rosenhöhe Hospital

Bielefeld, Germany,

Not yet recruiting

Germany,

MVZ Wiesbaden / KD Helios Clinic

Wiesbaden, Germany,

Recruiting

Spain,

Ruber International Hospital

Madrid, Spain,

Recruiting

Spain,

Ramón y Cajal University Hospital

Madrid, Spain,