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

NCT07066761 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-07-18

No results posted yet for this study

Summary

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.

Conditions

  • Pelvic Organ Prolapse (POP)
  • Genital Prolapse
  • Uterus Prolapse
  • Laparoscopic Surgery

Interventions

DEVICE

Laparoscopic lateral suspension with surgical mesh (LatGYNious)

Laparoscopic lateral suspension with LatGYNious (with uterus preservation or after hysterectomy)

Sponsors & Collaborators

  • A.M.I. Agency for Medical Innovations GmbH

    lead INDUSTRY

Principal Investigators

  • Tina Cadenbach-Blome, Dr. med. · Medizincampus Bodensee - Klinik Tettnang

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066761 on ClinicalTrials.gov