Clinical trials: Apical Prolapse
Pelvic Organ Prolapse
A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse
The purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the VFIX device).
- Trial name
- NCT00965952
- Where
- 4 sites in Australia
- Volunteers
- 49 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse
Post-market Clinical Follow-up of the SRS Implant
National, multicentre observational study on surgical reconstruction of the anterior and apical compartment of the pelvic floor with an SRS implant
- Trial name
- NCT05170074
- Where
- 6 sites in Germany
- Volunteers
- 97 people
- Sponsor
- pfm medical gmbh
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
Pelvic Organ Prolapse
Uphold LITE Post-Market Surveillance Study
The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Uphold LITE (NCT01917968)
- Testing
- Uphold Lightweight Vaginal Support System, Traditional native tissue repair
- Where
- 28 sites in United States
- Volunteers
- 289 people
- Sponsor
- Boston Scientific Corporation
Anterior Vaginal Wall Prolapse With/Without Apical/Uterine Descent
Multicenter, Prospective, Non-randomized, Single-arm, Interventional Study for the Evaluation of the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
- Trial name
- NCT03195361
- Testing
- SRS - Self Retaining Support system
- Where
- 3 sites in Israel
- Volunteers
- 50 people
- Sponsor
- Lyra Medical Ltd.
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
Pelvic Organ Prolapse
Study of the Elevate Apical and Posterior Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
The aim of this study is to further evaluate the safety and efficacy of the Elevate® Apical and Posterior Prolapse Repair System for repair of apical/posterior pelvic organ prolapse in a controlled, post-market cohort study.
- Trial name
- Harmony 522 (NCT02123992)
- Testing
- Elevate Apical and Posterior, Native Tissue Repair for pelvic organ prolapse
- Where
- 23 sites in United States
- Volunteers
- 99 people
- Sponsor
- ASTORA Women's Health
Pelvic Organ Prolapse
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
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
- Trial name
- SAXO (NCT05042453)
- Testing
- Splentis® POP Tissue Anchoring System
- Where
- 7 sites in Germany
- Volunteers
- 140 people
- Sponsor
- Promedon
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation
Pelvic Organ Prolapse
A Pilot Study to Evaluate the Clinical Effectiveness and Safety of the VFIX Device as Treatment for Apical Prolapse
The primary objective of this pilot study is to evaluate the safety and effectiveness of the VFIX device in maintaining vaginal apical support for at least 6 months in women with symptomatic apical prolapse (upper vaginal or…
- Trial name
- NCT01111409
- Testing
- VFIX Device
- Where
- 3 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Ethicon, Inc.
Cystocele, Rectocele
Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse
The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
- Conditions
- Cystocele, Rectocele, Enterocele
- Trial name
- NCT00833001
- Testing
- GYNECARE PROLIFT+M* Pelvic Floor Repair System
- Where
- 8 sites in Belgium, France and 2 more
- Volunteers
- 126 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle.
- Trial name
- NCT02162615
- Testing
- Restorelle Direct Fix A, Restorelle Direct Fix P, Native Tissue Repair Anterior
- Where
- 49 sites in United States, Australia and 4 more
- Volunteers
- 810 people
- Sponsor
- Coloplast A/S
Genital Prolapse
Real-Life Use of Transabdominal Restorelle® Meshes in Apical Prolapse Repair
The purpose of this study is to prospectively follow patients after a sacrocolpopexy with Restorelle® mesh for apical prolapse repair as part of routine care.
- Trial name
- REPAIR (NCT06296316)
- Testing
- Restorelle Polypropylene Mesh
- Where
- 6 sites in France
- Volunteers
- 39 people
- Sponsor
- Coloplast A/S
Pelvic Organ Prolapse
Study of the Elevate Anterior and Apical Prolapse Repair System Compared to Native Tissue Repair for Pelvic Organ Prolapse
The aim of this study is to further evaluate the safety and efficacy of the Elevate® Anterior and Apical Prolapse Repair System for repair of anterior/apical pelvic organ prolapse in a controlled, post-market cohort study.
- Trial name
- Embrace (NCT02121977)
- Testing
- Elevate Anterior and Apical, Native Tissue Repair for pelvic organ prolapse
- Where
- 31 sites in United States
- Volunteers
- 285 people
- Sponsor
- ASTORA Women's Health