Clinical trials: Pelvic Organ Prolapse
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.
Cystocele
Nerve Access Tool Study
The purpose of this study is to assess the ability of the nerve access tool to facilitate nerve stimulation lead placement.
- Trial name
- NCT00942474
- Testing
- Facilitate nerve stimulation lead placement with the nerve access tool
- Sponsor
- MedtronicNeuro
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.
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
Pelvic Organ Prolapse
Location and Anatomic Characterization of the Sacrospinous Ligaments in Women With Pelvic Organ Prolapse
Pelvic organ prolapse is a common disorder that results in significant patient morbidity. Approximately 1 in 9 women undergo surgery for the correction of pelvic organ prolapse (POP) and associated bladder and bowel dysfunction.
- Trial name
- NCT01852422
- Where
- Israel
- Sponsor
- Pop Medical Solutions
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
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
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
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 (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
Vaginal Prolapse
Clinical Assessment of the Total Vaginal Mesh Technique for Treatment of Genital Prolapse
Pelvic floor prolapse is a general term used to describe various clinical conditions that are associated with pelvic floor (muscles that support the vagina) relaxation in female patients.Pelvic floor prolapse is thought to result…
- Trial name
- NCT00196495
- Testing
- Polypropylene Mesh
- Volunteers
- 90 people
- Sponsor
- Ethicon, Inc.
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
Clinical Investigation to Evaluate Safety and Performance of the EndoFast Reliant™ System in Vaginal Wall Reinforcement
The purpose of this study is to clinically assess the safety and performance of the EndoFast Reliant™ system as a less invasive treatment for Pelvic Organ Prolapse.
- Trial name
- NCT00446693
- Testing
- EndoFast Reliant™ system for Pelvic Organ Prolapse repair
- Where
- 3 sites in France, Israel
- Volunteers
- 20 people
- Sponsor
- Endogun Medical Systems Ltd.
Cystocele, Uterine Prolapse
Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.
- Trial name
- NCT01084889
- Testing
- surgical mesh implantation (TiLOOP® Total 6)
- Where
- 9 sites in Germany
- Volunteers
- 292 people
- Sponsor
- pfm medical gmbh
Pelvic Organ Prolapse, Female Urogenital Diseases
Pelvic Organs Prolapse Treatment Using Neodymium Laser
The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Max" ("Magic Gyno" from August 2024) for preoperative treatment of pelvic organs prolapse I-II degree of severity.
- Trial name
- NCT05000957
- Testing
- Laser Treatment, Blood analysis, Сlinical urine test
- Where
- Russia
- Volunteers
- 129 people
- Sponsor
- MeLSyTech, Ltd
Vaginal Delivery, Pelvic Organ Prolapse
EASE: The Materna Prep Pivotal Study
This study is designed to evaluate the safety and effectiveness of the Materna Prep Device in reducing pelvic muscle injuries during vaginal delivery.
- Trial name
- NCT03973281
- Testing
- Materna Prep Device, Standard of Care (SOC)
- Where
- 22 sites in United States
- Volunteers
- 420 people
- Sponsor
- Materna Medical
Pelvic Organ Prolapse
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions
The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and…
- Trial name
- NCT02294383
- Where
- 2 sites in United States
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Artann Laboratories
Pelvic Organ Prolapse
ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse.
- Trial name
- NCT02021279
- Testing
- MatriStem Pelvic Floor Matrix, native tissue repair
- Where
- 13 sites in United States
- Volunteers
- 161 people
- Sponsor
- Integra LifeSciences Corporation
Pelvic Organ Prolapse, Cystocele
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
- Trial name
- NCT02258230
- Testing
- 3D mode of the 3D Laparoscopic Video System, 2D mode of the 3D Laparoscopic Video System
- Where
- 2 sites in United States
- Volunteers
- 194 people
- Sponsor
- Olympus Corporation of the Americas
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.