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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated March 20, 2026 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 6 to 5
    • Publications: details revised at 1 of 1 entry
    v8
  2. Primary completion date: Sep 2025 to Apr 2026
    • Study completion date: Sep 2025 to Sep 2026
    • Site details revised at 1 of 6 sites
    v7
  3. Site contacts updated at 1 of 6 sitesv6
  4. Site details revised at 1 of 6 sitesv5
  5. Site details revised at 4 of 6 sitesv4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Apr 1, 2023
    • Site details revised at 6 of 6 sites
    v3
  2. Interventions: Surgery for fecal incontinence (Procedure) to Medical Device (SimplyFI) (Procedure)
    • Secondary endpoints revised (2)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05708612
Lead Sponsor A.M.I. Agency for Medical Innovations GmbH
Conditions
(from sponsor)		 Fecal Incontinence
Related terms Fecal Incontinence
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov