Clinical trials: Vaginal Prolapse
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
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.
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.
Anterior Vaginal Wall Prolapse, Vaginal Apex/Uterine Prolapse
Demonstrate the Safety and Preformance of the SRS Device for the Treatment of Pelvic Organ Prolapse
A prospective, single arm, pre-market, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
- Trial name
- NCT02209337
- Testing
- SRS
- Where
- 3 sites in Hungary, Israel
- Volunteers
- 20 people
- Sponsor
- Lyra Medical Ltd.
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.
Pelvic Organ Prolapse
Feasibility Study of the Reia Vaginal Pessary
The purpose of this study is to obtain preliminary data on the effectiveness, safety, function, comfort, and patient satisfaction with a novel vaginal pessary design for the use in women who suffer from symptoms of pelvic organ…
- Trial name
- NCT04508335
- Testing
- Reia Vaginal Pessary
- Where
- 7 sites in United States
- Volunteers
- 78 people
- Sponsor
- Reia, LLC
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
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
Urinary Incontinence, Stress, Mixed Incontinence
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
The primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse.
- Conditions
- Urinary Incontinence, Stress, Mixed Incontinence, Vaginal Vault Prolapse
- Trial name
- NCT00223106
- Testing
- Vaginal Sling
- Where
- United States
- Volunteers
- 467 people
- Sponsor
- Medtronic - MITG
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
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
Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement
A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.
- Trial name
- NCT03516136
- Testing
- EndoFast Reliant SCP
- Volunteers
- 84 people
- Sponsor
- Allium, Ltd.
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
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
Surgical Intervention With DermaPure vs Native Tissue in Pelvic Organ Prolapse
Comparing FDA-approved DermaPure with patient's own native tissue surgically for diagnosis of pelvic organ prolapse.
- Trial name
- NCT03939715
- Testing
- DermaPure®, native tissue
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Colorado Pelvic Floor Consultants
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
Uterine Prolapse Without Vaginal Wall Prolapse
The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
- Trial name
- NCT03436979
- Testing
- NeuGuide™ System
- Where
- 15 sites in United States, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Pop Medical Solutions
Postmenopausal Period, Vaginal Atrophy
Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser
The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm.
- Conditions
- Postmenopausal Period, Vaginal Atrophy, Vaginal Prolapse
- Trial name
- NCT05335317
- Testing
- Laser Treatment, Topical hormone estriol, Сlinical blood analysis
- Where
- Russia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- MeLSyTech, Ltd
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