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, 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
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
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
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
Rectal Cancer, Colon Cancer
Perfusion Assessment in Laparoscopic Left Anterior Resection
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System ("PINPOINT System" or "PINPOINT") can assess viability of colon tissue during laparoscopic…
- Conditions
- Rectal Cancer, Colon Cancer, Crohn's Disease, Polyp
- Trial name
- PILLAR II (NCT01560377)
- Testing
- PINPOINT Endoscopic Fluorescence Imaging System
- Where
- 11 sites in United States
- Volunteers
- 147 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Brachial Ptosis
Evaluation of the Ulthera® System for Treatment of the Brachia
This study is an evaluation of the Ulthera® System used to treat the upper arms for improvement of brachial ptosis. All enrolled subjects will receive one bilateral upper arm treatment.
- Trial name
- NCT01713933
- Testing
- Ulthera® System
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Ulthera, 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
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
Hemorrhoid
Safety and Performance of the Covidien EEA Hemorrhoid and Prolapse Stapling Set in a Hemorrhoidopexy Procedure
Trial Objectives The primary objectives of this clinical trial are to estimate the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set: overall performance defined by the successful creation of a normal staple line safety as…
- Trial name
- NCT01169311
- Testing
- Hemorrhoidopexy
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Medtronic - MITG
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
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
Blepharoptosis
Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis
This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.
- Trial name
- NCT01848041
- Testing
- RVL-1201
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- RVL Pharmaceuticals, Inc.
Mitral Valve Insufficiency, Heart Valve Diseases
NeoChord TACT Post-Market Surveillance Registry
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
- Conditions
- Mitral Valve Insufficiency, Heart Valve Diseases, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT01784055
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 126 people
- Sponsor
- NeoChord
Pelvic Organ Prolapse
Xenform Postmarket Surveillance Study
To compare transvaginal repair with a biologic graft to traditional native tissue repair in women surgically treated for anterior and/or apical pelvic organ prolapse.
- Trial name
- Xenform (NCT01945580)
- Testing
- Prolapse Repair
- Where
- 25 sites in United States
- Volunteers
- 374 people
- Sponsor
- Boston Scientific Corporation