Clinical trials: Pelvic Organ Prolapse (POP)
Female Stress Incontinence, Pelvic Organ Prolapse
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
To monitor post-market performance through evaluation of short and long-term performance via: Efficacy Safety Patient reported outcomes
- Trial name
- CAPTURE (NCT01673360)
- Testing
- Elevate PC, Mini Arc Pro, RetroArc
- Where
- 19 sites in United States, Canada and 6 more
- Volunteers
- 401 people
- Sponsor
- ASTORA Women's Health
Pelvic Organ Prolapse (POP), Synthetic Mesh
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
The purpose of this clinical investigation is to collect clinical data about the ProGYNious Mesh based on a prospective clinical investigation.
- Conditions
- Pelvic Organ Prolapse (POP), Synthetic Mesh, Laparoscopic Surgery, Gynecologic Laparoscopic Surgery
- Trial name
- ProGYNious (NCT07497321)
- Testing
- Surgical mesh for pelvic organ prolapse repair (ProGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Pelvic Organ Prolapse (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
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
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
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
Pelvic Organ Prolapse (POP)
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
- Trial name
- (A&P) (NCT01378065)
- Testing
- Restorelle Direct Fix A&P
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- Coloplast A/S
Pelvic Organ Prolapse
Evaluation of Safety and Efficacy of the Apyx™ Device for the Repair of Pelvic Organ Prolapse (POP)
The aim of this study is to further evaluate this minimally invasive SSLF technique with respect to safety, clinical effectiveness, and patient satisfaction.
- Trial name
- NCT03991455
- Testing
- Apyx device
- Where
- Israel
- Volunteers
- 17 people
- Sponsor
- Escala Medical LTD
Pelvic Organ Prolapse
Validation of Transvaginal Tactile Imaging
The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the…
- Trial name
- VTI-03 (NCT01491334)
- Where
- 2 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Artann Laboratories
Prolapse, Sacrocolpopexy
Retrospective Data Analysis PelviGYNious/EndoGYNious
The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
- Conditions
- Prolapse, Sacrocolpopexy, Pelvic Organ Prolapse (POP)
- Trial name
- NCT06927752
- Testing
- PelviGYNious, EndoGYNious
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Stress Urinary Incontinence, Pelvic Organ Prolapse
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including…
- Trial name
- NCT04829175
- Testing
- Intervention
- Where
- 10 sites in United States, Austria and 5 more
- Volunteers
- 1,000 people
- Sponsor
- Ethicon, Inc.
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
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
- Trial name
- NCT04829058
- Testing
- Intervention
- Where
- 3 sites in United States, Germany
- Volunteers
- 64 people
- Sponsor
- Ethicon, Inc.
Pelvic Organ Prolapse
Exair® Versus Native Tissue Repair for Prolapse
The purpose of this study is to compare safety and effectiveness of the Exair Prolapse Repair System for treatment of pelvic organ prolapse to traditional native tissue repair through 36 months of follow-up.
- Trial name
- NCT02162628
- Testing
- Exair Prolapse Repair System, Total Native Tissue Repair
- Where
- 14 sites in United States, Canada
- Volunteers
- 79 people
- Sponsor
- Coloplast A/S
Pelvic Organ Prolapse
R&D Supporting Pilot Study for the Assessment of the Safety and Effectiveness of the ProVATE (ProTIPI) Vaginal Pessary
The study includes five (5) main stages: Screening, Enrollment, Size fitting, Usage and Termination. Subject screening will be held during visit one (1) and visit two (2) at the clinic.
- Trial name
- NCT02239133
- Testing
- ProVATE vaginal pessary
- Where
- 3 sites in Israel
- Volunteers
- 44 people
- Sponsor
- ConTIPI Medical
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