Clinical trials: Replacement
Mitral Regurgitation, Mitral Insufficiency
ATLAS (AltaValve) Pivotal Trial
This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
- Conditions
- Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Incompetence, Mitral Valve Regurgitation
- Trial name
- ATLAS (NCT06465745)
- Testing
- AltaValve System.
- Where
- 58 sites in United States, Canada and 5 more
- Volunteers
- 450 people
- Sponsor
- 4C Medical Technologies, Inc.
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE Study
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
- Trial name
- CADENCE (NCT02688153)
- Testing
- EDWARDS INTUITY, Stented aortic bioprostheses
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Edwards Lifesciences
Arthroplasty, Replacement, Knee
Signature Personalised Patient Care System With the Vanguard Knee System Study
The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of…
- Trial name
- NCT01092312
- Testing
- Vanguard Knee System with Signature Knee Guide, Vanguard Knee System with conventional Instruments
- Where
- 12 sites in United States, Australia and 8 more
- Volunteers
- 325 people
- Sponsor
- Zimmer Biomet
Arthroplasty, Replacement, Knee, Blood Transfusion, Autologous
A Clinical Study to Investigate if Transfusion of Patients Own Shed Blood Improves the Immunological Status in Comparison to Transfusion of Donor Blood ("Bank Blood")
The primary objective of the study is to compare the immunological status after either autologous blood transfusion as administered by Bellovac® ABT or allogenic blood transfusion, with regards to change in Natural Killer (NK)…
- Conditions
- Arthroplasty, Replacement, Knee, Blood Transfusion, Autologous, Blood Transfusion
- Trial name
- NCT00839241
- Testing
- Bellovac ABT, Allogenic Blood Transfusion
- Where
- Poland
- Volunteers
- 45 people
- Sponsor
- Wellspect HealthCare
Hypothyroidism
A Study Evaluating the Safety and Efficacy of Hormone Replacement Therapy With ST-1891 Compared to Levothyroxine in Patients With Primary Hypothyroidism
ST-1891-201 is a multicenter, randomized, double-blind, partial crossover, Phase 2 study evaluating the safety and efficacy of hormone replacement therapy with ST-1891 compared to levothyroxine in patients with primary…
- Trial name
- NCT05412979
- Testing
- ST-1891, Levothyroxine
- Where
- 39 sites in United States
- Volunteers
- 490 people
- Sponsor
- Sention Therapeutics, LLC
Mitral Valve Regurgitation
First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve System
The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
- Trial name
- NCT04775108
- Testing
- Epygon™ Transcatheter Mitral Valve System
- Where
- 10 sites in Austria, Italy and 2 more
- Volunteers
- 40 people
- Sponsor
- Epygon
Knee Osteoarthritis
Long-term Study of The Press Fit Condylar (P.F.C.) Sigma Total Knee Replacement System
The main purpose of this study is to record information from clinical and radiographic examinations and patient assessment questionnaires before surgery and at suitable postoperative intervals to assess the functioning and…
- Trial name
- NCT00734110
- Testing
- P.F.C. Sigma Total Knee System
- Where
- United Kingdom
- Volunteers
- 723 people
- Sponsor
- DePuy International
Fabry Disease
Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-naïve Adult Male Patients With Fabry Disease
Primary Objective: To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.
- Trial name
- NCT02228460
- Testing
- GZ/SAR402671
- Where
- 8 sites in United States, France and 3 more
- Volunteers
- 11 people
- Sponsor
- Genzyme, a Sanofi Company
Osteoarthritis, Degenerative Arthritis
Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study
The purpose of this study is to compare the performance of two FDA-cleared tibial bearings (replacement for cartilage in the knee) by collecting data on patients through 3 years of follow-up.
- Trial name
- VGASPS (NCT01308515)
- Testing
- Vanguard Knee System with AS Bearing, Vanguard Knee System with PS Bearing
- Sponsor
- Zimmer Biomet
Cervical Degenerative Disc Disease
Real World Data Collection on the Synergy Disc
This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts.
- Trial name
- NCT06383949
- Testing
- Synergy Cervical Disc system
- Where
- Ireland
- Volunteers
- 50 people
- Sponsor
- Synergy Spine Solutions
Surgical Robotics, Knee Replacement
A Retrospective Study of the Navio Robotic-assisted Surgical System
A retrospective, multi-center, cohort study with prospective follow-up and comparison to historical control
- Trial name
- NAVIO (NCT03072459)
- Where
- 5 sites in United States
- Volunteers
- 128 people
- Sponsor
- Smith & Nephew, Inc.
Arthroplasty, Replacement, Shoulder
S-33 SMR Shoulder HP Reverse Glenosphere
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision…
- Trial name
- NCT05339815
- Testing
- SMR shoulder arthroplasty
- Where
- United Kingdom
- Volunteers
- 205 people
- Sponsor
- Limacorporate S.p.a
Knee Osteoarthritis, Disuse Atrophy
Effects of Kneehab 12-week Peri-operative Total Knee Arthroplasty
Determine the efficacy of neuromuscular electrical stimulation (NMES, Kneehab) in promoting accelerated recovery of quadriceps function in patients recovering from total knee arthroplasty (TKA) as measured by increases in…
- Trial name
- KneehabTKA (NCT01096524)
- Testing
- Standard Physiotherapy, Kneehab
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Bio-Medical Research, Ltd.
Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis
Clinical and Radiological Results of Total Hip Arthroplasty Using a Ceramic Friction Pair
The aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a Meije Duo® femoral stem associated with a Dynacup® cup, and using the friction pair Biolox® Delta Ceramic.
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations
- Trial name
- CERAM (NCT02062437)
- Volunteers
- 132 people
- Sponsor
- Stryker Trauma and Extremities
Osteoarthritis, Degenerative Arthritis
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if…
- Conditions
- Osteoarthritis, Degenerative Arthritis, Traumatic Arthritis
- Trial name
- NCT02820766
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- Smith & Nephew, Inc.
Tricuspid Regurgitation
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery.
- Trial name
- NCT05436028
- Testing
- Transcatheter Tricuspid Valve Intervention
- Where
- France
- Volunteers
- 161 people
- Sponsor
- Jenscare Scientific
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
The primary objectives of this study are to assess the safety and efficacy of MS1819-SD vs porcine pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
- Trial name
- OPTION (NCT03746483)
- Testing
- MS1819, Porcine PERT
- Where
- 14 sites in United States, Poland
- Volunteers
- 41 people
- Sponsor
- Entero Therapeutics
Acute Lung Injury, Acute Kidney Injury
Safety and Efficacy Evaluation of CO2 Removal in Combination With Continuous Veno-Venous Hemodialysis/Hemodiafiltration Therapy
Objective of the study is to assess the safety and efficacy of CO2 removal by the multiECCO2R (CO2 Removal System) on the multiFiltrate/multiFiltrate Pro in veno-venous extracorporeal circulation during continuous renal…
- Conditions
- Acute Lung Injury, Acute Kidney Injury, Hypercapnia, Covid19
- Trial name
- multiECCO2R (NCT04871893)
- Testing
- multiECCO2R blood-gas exchanger
- Where
- 6 sites in Germany
- Volunteers
- 28 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Osteoarthritis: Joint Replacement Surgery
Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
Total knee arthroplasty (TKA) is the most common joint replacement surgery and its incidence is expected to increase 673% to 3.48 million procedures annually by 2030.
- Trial name
- NCT03912116
- Testing
- CLARIX FLO, Saline
- Where
- United States
- Sponsor
- BioTissue Holdings, Inc
Osteoarthritis
Medacta GMK Sphere® Multicenter Post-Market Outcomes Study
This study is to average Forgotten Knee Score (FJS) of those patients receiving the Medacta GMK Sphere® knee at the two and five year time points.
- Trial name
- NCT02501733
- Testing
- Medacta GMK Sphere® Medial Knee Prosthesis
- Where
- 5 sites in United States
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Medacta USA