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Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from A.M.I. Agency for Medical Innovations GmbH

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Dec 2026 to Dec 2027
    • Start date: Jul 1, 2025 to Nov 1, 2025
    • Study completion pushed from Jul 2027 to Apr 2028
    • Study sites revised (5)
    v3
  2. Site contacts updated at 1 of 5 sitesv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
Trial Details
NCT Number NCT07066761
Lead Sponsor A.M.I. Agency for Medical Innovations GmbH
Conditions
(from sponsor)		 Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
Related terms Pelvic Organ Prolapse, Uterine Prolapse
Enrollment 85 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov