Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
NCT05042453 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140
Last updated 2024-11-22
Summary
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
Conditions
- Pelvic Organ Prolapse
Interventions
- DEVICE
-
Splentis® POP Tissue Anchoring System
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
Sponsors & Collaborators
-
Promedon
lead INDUSTRY
Principal Investigators
-
Gert Naumann, MD · Helios Clinic Erfurt, Germany
-
Christian Fünfgeld, MD · Clinic Tettnang
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-19
- Primary Completion
- 2026-07-31
- Completion
- 2030-07-31
Countries
- Germany
Study Locations
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