Clinical trials: Procidentia
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
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
Volume Loss (Soft Tissue Ptosis or Atrophy )
Pan Facial Volume Restoration
The aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction further to pan-facial volume restoration with a new cross-linked hyaluronic acid dermal filler containing lidocaine…
- Trial name
- EVE (NCT01545557)
- Testing
- Hyaluronic acid dermal filler gel
- Where
- 3 sites in Brazil
- Volunteers
- 60 people
- Sponsor
- Galderma R&D
Rectocele, Enterocele
A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of…
- Conditions
- Rectocele, Enterocele, Rectal Prolapse
- Trial name
- POP-01 (NCT04564677)
- Testing
- Ifabond (Péters surgical)
- Where
- Belgium
- Volunteers
- 150 people
- Sponsor
- Duomed
Mitral Valve Prolapse
St. Jude Medical Percutaneous Mitral Valve Repair Study
The purpose of this proof-of-concept study is to assess the relative safety and feasibility of the SJM Percutaneous Mitral Valve Repair (PMVr) Device.
- Trial name
- SJM PMVr (NCT01500148)
- Testing
- PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)
- Where
- United Kingdom
- Volunteers
- 2 people
- Sponsor
- Abbott Medical Devices
Dermatochalasis of Upper Eyelid, Ptosis, Eyelid
Comparative Study of Ziplyft Treatment vs. Traditional Blepharoplasty for Upper Eyelid Rejuvenation
This study will compare two surgery techniques used for upper eyelid (eyelift) surgery: traditional surgery and a newer method called Ziplyft (a non-powered, hand-held clamp).
- Conditions
- Dermatochalasis of Upper Eyelid, Ptosis, Eyelid, Blepharoplasty
- Trial name
- NCT07250139
- Testing
- Ziplyft Device, Comparator Arm: Standard Blepharoplasty
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Osheru Inc.
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
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
Mitral Valve Regurgitation, Mitral Valve Prolapse
CE Mark Study for the Harpoon Medical Device
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- TRACER (NCT02768870)
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 4 sites in Italy, United Kingdom
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
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
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Observational Registry on the HARPOON Device
To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
- Trial name
- REPLICATE (NCT04393779)
- Testing
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Where
- 7 sites in Germany, Spain and 1 more
- Volunteers
- 26 people
- Sponsor
- Edwards Lifesciences
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
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, Cystocele
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.
- Trial name
- NCT02258230
- Testing
- 3D mode of the 3D Laparoscopic Video System, 2D mode of the 3D Laparoscopic Video System
- Where
- 2 sites in United States
- Volunteers
- 194 people
- Sponsor
- Olympus Corporation of the Americas
Constipation
International Multicenter Prospective Transtar Registry
Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the feeling of not having emptied…
- Trial name
- NCT00909116
- Testing
- Stapled Transanal Rectal Resection with Contour Transtar
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Ethicon Endo-Surgery (Europe) GmbH
Pelvic Organ Prolapse
A Pilot Study to Investigate the Efficacy of Partially Absorbable Mesh in Patients With Pelvic Organ Prolapsed
The purpose of this study is to evaluate the efficacy, recurrence, postoperative complications of partially absorbable mesh(Seratom®PA) in patients with pelvic organ prolapse.
- Trial name
- NCT02320643
- Testing
- Seratom® PA mesh
- Where
- South Korea
- Volunteers
- 50 people
- Sponsor
- Samyang Biopharmaceuticals Corporation
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
Senile Ptosis
Evaluation of Patient and Physician Satisfaction With the Zift eLevatIon of Facial Tissue Clinical Study
The LIFT study will document the first clinical use of the ZiftLift Tissue Anchor in a browlift for patients with age-related brow ptosis.
- Trial name
- LIFT (NCT03055819)
- Testing
- Brow Lift
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Zift, LLC
Pelvic Organ Prolapse
Long-term Evaluation of the Efficacy and Safety of Splentis for the Treatment of Primary Apical Pelvic Organ Prolapse
This prospective, multi center cohort trial aims to evaluate the efficacy and safety of hysteropexy using Splentis via the vaginal route in primary uterine prolapse
- Trial name
- SAXO (NCT05042453)
- Testing
- Splentis® POP Tissue Anchoring System
- Where
- 7 sites in Germany
- Volunteers
- 140 people
- Sponsor
- Promedon