Clinical trials: Pelvic Floor Prolapse
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
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
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
Pelvic Floor Repair Systems for Prolapse Repair
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for…
- Trial name
- PROPEL (NCT00638235)
- Testing
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, AMS Perigee™ with IntePro
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 725 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
Vaginal Tactile Imaging for Pelvic Floor Prolapse
The investigators will analyze biomechanical transformation of pelvic floor tissues and support structures under affected pelvic floor conditions and repaired states after the surgery.
- Trial name
- NCT02925585
- Testing
- Pre/post imaging
- Where
- 5 sites in United States
- Volunteers
- 119 people
- Sponsor
- Artann Laboratories
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 (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 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
Vaginal Vault Prolapse
Study of Cytrix Use in Pelvic Floor Prolapse Treatment
To evaluate safety and effectiveness of using the fetal bovine dermis (Cytrix) in the treatment of pelvic organ prolapse.
- Trial name
- NCT01244165
- Testing
- Cytrix, Other treatments for pelvic organ prolapse
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
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
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
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
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
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.
Internal Rectal Prolapse, Pelvic Floor Ptosis
Clinical Study for the Evaluation of the Efficiency of a Device for the Diagnosis of an Internal Rectal Prolapse, a Pelvic Floor Ptosis and for the Determination of an Internal Hernia Into the Douglas Pouch
The purpose of this study is to determine if the device is supplying sufficient diagnosis results of an internal rectal prolapse, of a pelvic floor ptosis and for the determination of an interal hernia into the Douglas pouch, as…
- Conditions
- Internal Rectal Prolapse, Pelvic Floor Ptosis, Internal Hernia Into the Douglas Pouch
- Trial name
- NCT00836680
- Testing
- Colorectal Stent
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- Gerhard Pejcl Medizintechnik GmbH
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
Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair
Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement
- Trial name
- CASPO (NCT03821142)
- Testing
- Transvaginal mesh for anterior pelvic organ prolapse repair
- Where
- 6 sites in Germany
- Volunteers
- 180 people
- Sponsor
- Promedon
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