Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
NCT ID: NCT05042453
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
140 participants
OBSERVATIONAL
2022-12-19
2030-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Hysteropexy using Splentis via vaginal route
Non-fertile women ≥ 18 years with uterine descent (POP-Q ≥ 2) which are study-independently scheduled for hysteropexy with Splentis
Splentis® POP Tissue Anchoring System
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
Interventions
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Splentis® POP Tissue Anchoring System
Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
Eligibility Criteria
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Inclusion Criteria
* primary symptomatic uterine descent POP-Q≥2
* Scheduled apical POP repair with Splentis
* Willing and able to participate at study visits and to sign informed consent
Exclusion Criteria
* Recurrent apical prolapse
* Women with post hysterectomy vaginal vault prolapse
* Patients with active or latent infection of the vagina, cervix or uterus
* Patients with previous or current vaginal, cervical or uterine cancer
* Previous, current or planned pelvic radiation therapy
* Known allergy to polypropylene.
18 Years
FEMALE
No
Sponsors
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Promedon
INDUSTRY
Responsible Party
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Principal Investigators
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Gert Naumann, MD
Role: PRINCIPAL_INVESTIGATOR
Helios Clinic Erfurt, Germany
Christian Fünfgeld, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic Tettnang
Locations
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DRK Hospital Chemnitz-Rabenstein
Chemnitz, , Germany
Helios Hospital Erfurt, Department of gynaecology
Erfurt, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
Clinic Kassel
Kassel, , Germany
St. Elisabeth Hospital
Leipzig, , Germany
University Hospital
Mannheim, , Germany
Hospital Tettnang
Tettnang, , Germany
Countries
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Central Contacts
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Facility Contacts
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Torsten Brosche, Dr. med.
Role: primary
Gert Naumann, PD Dr.habil.
Role: primary
Markus Hübner, Prof. Dr. med.
Role: primary
Christiane Schiffner, Dr. med.
Role: primary
Birgit Henne, Dr. med.
Role: primary
Benjamin Tuschy, Prof. Dr. med.
Role: primary
Christian Fünfgeld, Dr.med.
Role: primary
Other Identifiers
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Sax_Pro
Identifier Type: -
Identifier Source: org_study_id
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