Clinical trials: Ptosis
Breast Ptosis
A Post-Market Study in Greece of a Minimally Invasive Breast Lift Procedure Utilizing the Renuvion APR System
This is a prospective, non-randomized, single-center, evaluator blinded study of up to 15 subjects undergoing a minimally invasive breast lift procedure utilizing the Renuvion APR System.
- Trial name
- NCT05665335
- Testing
- Renuvion APR System
- Where
- Greece
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Apyx Medical
Pelvic Organ Prolapse
Pelvic Floor Repair Systems for Prolapse Repair
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for…
- Trial name
- PROPEL (NCT00638235)
- Testing
- AMS Apogee™ with IntePro, AMS Apogee™ with Intexen LP, AMS Perigee™ with IntePro
- Where
- 28 sites in United States, Belgium and 5 more
- Volunteers
- 725 people
- Sponsor
- ASTORA Women's Health
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
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
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
Blepharoptosis
Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
- Trial name
- NCT03565887
- Testing
- RVL-1201, Vehicle ophthalmic solution
- Where
- 36 sites in United States
- Volunteers
- 164 people
- Sponsor
- RVL Pharmaceuticals, Inc.
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
Lower Eyelid Steatoblepharon (Excess Eyelid Fat)
Phase 2 Study of XAF5 (XOPH5) Ointment for Reduction of Excess Eyelid Fat (Steatoblepharon)
This study will test whether XAF5 (XOPH5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).
- Trial name
- NCT02230761
- Testing
- XOPH5 Ointment
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Topokine Therapeutics, Inc.
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Real World Expanded Multicenter Study of the MitraClip® System (REALISM)
Prospective, multicenter, continued access registry of the MitraClip® Cardiovascular Valve Repair System in the treatment of mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- REALISM (NCT01931956)
- Testing
- MitraClip® implant
- Where
- 38 sites in United States
- Volunteers
- 965 people
- Sponsor
- Abbott Medical Devices
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
Breast Ptosis, Obesity
Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
- Trial name
- NCT00959374
- Testing
- V-Loc 180/90 Wound Closure Device, 3-0 Monocryl Absorbable Sutures
- Where
- 8 sites in United States, Germany
- Volunteers
- 229 people, healthy volunteers welcome
- 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
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
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
Blepharoptosis
Study of Safety of RVL-1201 in Treatment of Blepharoptosis
Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.
- Trial name
- NCT03536949
- Testing
- RVL-1201, Vehicle ophthalmic solution
- Where
- 35 sites in United States
- Volunteers
- 234 people
- Sponsor
- RVL Pharmaceuticals, Inc.
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
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
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
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