Clinical trials: Procidentia
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Hemorrhoids
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Trial name
- HEMOSTASIS (NCT01306877)
- Testing
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Medtronic - MITG
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
Mitral Regurgitation, Mitral Valve Disease
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse
- Trial name
- AcChord (NCT04190602)
- Testing
- NeoChord Artificial Chordae Delivery System, Model DS1000
- Where
- 5 sites in Germany, Greece and 1 more
- Volunteers
- 500 people
- Sponsor
- NeoChord
Pelvic Organ Prolapse, Prolapse
Early Feasibility Study of the Reia Vaginal Pessary
This is an early feasibility open-label non-randomized trial to obtain preliminary information about the function and effectiveness of a novel vaginal pessary for the use in women who suffer from symptoms of pelvic organ prolapse…
- Trial name
- NCT04275089
- Testing
- Reia Vaginal Pessary
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Reia, LLC
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.
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
Pelvic Organ Prolapse
Uphold LITE Post-Market Surveillance Study
The purpose of this study is to compare transvaginal mesh repair to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Uphold LITE (NCT01917968)
- Testing
- Uphold Lightweight Vaginal Support System, Traditional native tissue repair
- Where
- 28 sites in United States
- Volunteers
- 289 people
- Sponsor
- Boston Scientific Corporation
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
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
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
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.
Pelvic Organ Prolapse
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
- Trial name
- NCT04829058
- Testing
- Intervention
- Where
- 3 sites in United States, Germany
- Volunteers
- 64 people
- Sponsor
- Ethicon, Inc.
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
Thymidine Kinase 2 (TK2)
A RETROspective Study of Patients With TK2d
This is a medical chart review study to collect information for patients who have been taking pyrimidine nucleosides for treatment of TK2 deficiency.
- Trial name
- RETRO (NCT03701568)
- Testing
- dC/dT
- Where
- 8 sites in United States, Israel and 1 more
- Volunteers
- 38 people
- Sponsor
- Zogenix MDS, Inc.
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
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
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
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
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