Clinical trials: Pelvic Prolapse
Vaginal Wall Prolapse
Surgical Repair of Vaginal Wall Prolapse Using Gamma Irradiated Amniotic Membrane as a Scaffold
The surgical repair of vaginal wall prolapse continues to remain one of the most difficult challenges in female pelvic floor reconstruction. The recurrence rate after standard colporrhaphy ranges from 40-60 %.
- Trial name
- NCT05355623
- Testing
- Vaginal Repair
- Where
- Egypt
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Egymedicalpedia
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
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
Diverticulum, Colon, Colorectal Neoplasms
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- RETROPRESS (NCT01301417)
- Testing
- ColonRing™
- Where
- United States
- Volunteers
- 171 people
- Sponsor
- novoGI
Rectal Prolapse
Safety and Performance Evaluation of a Biological Matrix Used for Rectal Prolapse Repair by Ventral Rectopexy
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Rectopexy membrane used in rectal prolapse repair by ventral rectopexy and to identify emerging risks in…
- Trial name
- NCT04130555
- Testing
- CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)
- Where
- 3 sites in France
- Volunteers
- 55 people
- Sponsor
- Meccellis Biotech
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 Floor Disorders, Pelvic Pain
Digital Care Programs for Female Pelvic Health
The purpose of this study is to create a research repository, composed of data collected in the course of digital care programs for pelvic health conditions by SWORD Health/Bloom to individuals undergoing those programs.
- Conditions
- Pelvic Floor Disorders, Pelvic Pain, Pelvic Organ Prolapse, Pelvic Floor Muscle Weakness
- Trial name
- NCT05513417
- Testing
- Bloom Pod
- Where
- United States
- Volunteers
- 50,000 people, healthy volunteers welcome
- Sponsor
- Sword Health, SA
Vaginal Vault Prolapse
Laparoscopic Versus Vaginal Approach Closure Complications
Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally.
- Trial name
- NCT05960292
- Testing
- Laparoscopic and Vaginal Hysterectomy
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Egymedicalpedia
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
Vaginal Delivery, Pelvic Organ Prolapse
Materna Prep Study Phase II
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
- EASE (NCT06126328)
- Testing
- Materna Prep Device
- Where
- 15 sites in United States
- Volunteers
- 214 people
- Sponsor
- Materna Medical
Pelvic Organ Prolapse
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study
This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
- Trial name
- NCT01541748
- Testing
- Axis
- Where
- 5 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Pelvic Organ Prolapse
GYNECARE PROSIMA* Pelvic Floor Repair System for Pelvic Organ Prolapse
The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP. (*TRADEMARK)
- Trial name
- NCT00521066
- Testing
- GYNECARE PROSIMA* Pelvic Floor Repair System
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 150 people
- Sponsor
- Ethicon, Inc.
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
Pelvic Organ Prolapse, Genital Prolapse
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.
- Trial name
- i-StitchSSLF (NCT06805006)
- Testing
- SSLF
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Pelvic Organ Prolapse
Soft Tissue Graft for Repair of Pelvic Organ Prolapse
The purpose of this Study is to collect information about the performance of the Surgisis® Soft Tissue Graft ("Study Product") for the repair of pelvic organ prolapse in women.
- Trial name
- POP (NCT01827774)
- Testing
- Surgisis® Soft Tissue Graft
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Cook Group Incorporated
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
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
Pelvic Organ Prolapse
Development Study Using Vaginal Tactile Imager
The objective is to evaluate and optimize tactile imaging technology in evaluation of tissue elasticity parameters in the female pelvis.
- Trial name
- NCT01111916
- Where
- 2 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Artann Laboratories
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
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