Clinical trials: Genital Prolapse
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
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 (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
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
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
Thymoma, Mediastinal Tumor
Clinical Investigation of the da Vinci Surgical System
This prospective, multicenter, single-arm study is being conducted to confirm safety, effectiveness, and usability of da Vinci Surgical System in performing robotic-assisted surgical procedures.
- Conditions
- Thymoma, Mediastinal Tumor, Gynecologic Disease, Gynecologic Cancer
- Trial name
- NCT05682742
- Testing
- Robotic-assisted Surgery
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Intuitive Surgical
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
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
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
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
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
Diverticulum, Colon, Colorectal Neoplasms
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing
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 4-6 centers.
- Conditions
- Diverticulum, Colon, Colorectal Neoplasms, Crohn Disease, Colitis, Ulcerative
- Trial name
- NCT01880918
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- novoGI
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, 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
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
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.
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
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