Clinical trials: Uterine Prolapse
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 (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
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
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
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
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
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
Cystocele, Uterine Prolapse
Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh
The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.
- Trial name
- NCT02690220
- Testing
- TiLOOP® PRO Plus A
- Where
- 5 sites in Germany
- Volunteers
- 54 people
- Sponsor
- pfm medical gmbh
Female Urogenital Diseases, Urinary Incontinence
Clinical Trial of "Magic Gyno" Laser Device
The aim of this prospective study is investigation of efficiency and safety of medical device "Magic Gyno" in accordance with the stated purpose.
- Conditions
- Female Urogenital Diseases, Urinary Incontinence, Prolapse Genital, Menopausal Syndrome
- Trial name
- NCT05463081
- Testing
- Laser treatment, Blood test, Clinical urine test
- Where
- Russia
- Volunteers
- 70 people
- Sponsor
- MeLSyTech, Ltd
Uterine Fibroids (UF), Menstrual Disorders
Hugo™ Robotic-Assisted Surgery (RAS) System in Gynecological Subjects (Embrace Gynecology)
The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugo™ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for…
- Conditions
- Uterine Fibroids (UF), Menstrual Disorders, Adenomyosis of Uterus, Endometriosis
- Trial name
- Embrace Gyn (NCT07120945)
- Testing
- Robotic Assisted-Surgery (RAS) Hysterectomy
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Medtronic - MITG
Vaginal Prolapse
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry).
- Trial name
- POWER1012 (NCT00388947)
- Testing
- AMS Prolapse Product
- Where
- United States
- Volunteers
- 1,543 people
- Sponsor
- ASTORA Women's Health
Abnormal Uterine Bleeding, Endometriosis
Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy
The aim of this study is to show the superiority of the new unidirectional barbed suture (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to perform the vaginal cuff closure during gynecologic…
- Conditions
- Abnormal Uterine Bleeding, Endometriosis, Uterine Prolapse, Uterine Cancer
- Trial name
- BARHYSTER (NCT06024109)
- Testing
- Closure of the Vaginal Cuff after Total Hysterectomy
- Where
- 2 sites in Germany, Spain
- Volunteers
- 132 people
- Sponsor
- Aesculap AG