Clinical trials: Replacement
Osteoarthritis
A Retrospective Study of the iTotal CR Knee Replacement System
This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.
- Trial name
- NCT01564654
- Testing
- iTotal KRS
- Where
- 4 sites in United States
- Volunteers
- 89 people
- Sponsor
- Restor3D
Cardiac Implantable Electronic Device Infection
TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device…
- Trial name
- Centurion (NCT01043705)
- Where
- 52 sites in United States
- Volunteers
- 1,262 people
- Sponsor
- TYRX, Inc.
Osteoarthritis, Traumatic Arthritis
A Clinical Investigation of the Vanguard™ Complete Knee System
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Vanguard™ Complete Knee System.
- Conditions
- Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Lower Limb Deformity
- Trial name
- NCT00698854
- Testing
- Vanguard™ Complete Knee System, Vanguard™ Patient-Specific Femur
- Where
- 8 sites in United States
- Volunteers
- 552 people
- Sponsor
- Zimmer Biomet
Arthropathy of Knee, Arthropathy of Hip
Nirvana Super Pro Supplementation in Orthopedic Surgery Patients
The purpose of this study is to investigate orthopedic patients undergoing either a total hip replacement (THR) or total knee arthroplasty (TKR) using two dietary supplements, PREPARE and RECOVER, and their recovery times…
- Trial name
- NCT06203691
- Testing
- Supplementation with Nirvana Super Pro Liquid Supplements, Non-Supplementation Group
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nirvana Water Sciences Corp
Tricuspid Regurgitation (TR)
LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation
This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd.
- Trial name
- NCT07705594
- Testing
- Transvenous Tricuspid Valve System implantation + OMT, OMT
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jenscare Scientific
Symptomatic Degenerative Aortic Stenosis, Severe Aortic Stenosis
CONFIDENCE Registry to Assess Safety and Performance of Portico System to Treat Patients With Severe Aortic Stenosis.
The purpose of this clinical investigation is to characterize the procedural safety and device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in patients with symptomatic degenerative…
- Trial name
- NCT03752866
- Testing
- Portico™ Valve, Portico Delivery System(s) and Loading System(s), Portico™ Valve, FlexNav Delivery System(s) and Loading System(s)
- Where
- 28 sites in Australia, Belgium and 7 more
- Volunteers
- 1,001 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis
Detecting Changes in Arterial Blood Volume and Cardiac Efficiency
The objective of this Pilot Study is to demonstrate the efficacy of the Hemocept device in detecting changes in arterial blood volume and cardiac efficiency.
- Trial name
- NCT07205341
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- HemoCept Inc.
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.
Mitral Regurgitation
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
Study to evaluate the feasibility, safety and performance of the HighLife trans-septal Transcatheter Mitral Valve in patients with moderate-severe and severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029337
- Testing
- Transcatheter Mitral Valve Replacement
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Venous Thrombosis
Evaluation of PD 0348292 for Preventing Blood Clots in the Lungs or Deep Leg Veins of Patients After Knee Surgery
To study the safety and effectiveness of several doses of PD 0348292 compared to enoxaparin in preventing blood clots in the lungs or deep leg veins of patients after knee surgery
- Trial name
- NCT00306254
- Testing
- PD 0348292, Enoxaparin
- Where
- 134 sites in United States, Australia and 14 more
- Volunteers
- 1,225 people
- Sponsor
- Pfizer
Aortic Valve Stenosis
REPRISE IV: LOTUS Edge Valve System in Intermediate Surgical Risk Subjects
REPRISE IV: REpositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of LOTUS Edge Valve System in IntermediatE Surgical Risk Subjects
- Trial name
- REPRISE IV (NCT03618095)
- Testing
- LOTUS Edge Valve System
- Where
- 50 sites in United States, Australia
- Volunteers
- 382 people
- Sponsor
- Boston Scientific Corporation
Tobacco Dependence
Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.
- Trial name
- NCT01234792
- Testing
- 6 mg Experimental nicotine gum, 4 mg Nicotine Gum/, 2 mg Nicotine Gum
- Where
- Sweden
- Volunteers
- 24 people
- Sponsor
- McNeil AB
Postmenopause
Endometrial Safety Study of a 0.5 mg Estradiol and 2.5 mg Dydrogesterone Combination
The purpose of this study is to demonstrate endometrial safety of continuous combined 0.5 mg estradiol and 2.5 mg dydrogesterone.
- Trial name
- NCT00160316
- Testing
- 0.5 Mg Estradiol and 2.5 Mg Dydrogesterone
- Where
- 22 sites in Croatia, Poland and 2 more
- Volunteers
- 454 people
- Sponsor
- Solvay Pharmaceuticals
Coronary Artery Disease, Mitral Valve Regurgitation
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures…
- Conditions
- Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
- Trial name
- NCT00853632
- Testing
- CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
- Where
- 15 sites in United States, Austria and 2 more
- Volunteers
- 329 people
- Sponsor
- Edwards Lifesciences
Gaucher Disease, Type 3
Efficacy and Safety Study of Velaglucerase Alfa in Children and Adolescents With Type 3 Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by the deficiency of the enzyme glucocerebrosidase (GCB). Gaucher disease has been classified into 3 clinical subtypes based on the presence or absence of neurological…
- Trial name
- NCT01685216
- Testing
- velaglucerase alfa
- Where
- 5 sites in Egypt, India and 1 more
- Volunteers
- 7 people
- Sponsor
- Shire
Mitral Regurgitation
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in…
- Trial name
- APOLLO-EU (NCT05496998)
- Testing
- Medtronic Intrepid™ TMVR TF System
- Where
- 37 sites in Denmark, France and 6 more
- Volunteers
- 400 people
- Sponsor
- Medtronic Cardiovascular
Degenerative Disc Disease
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
- Trial name
- XL TDR (NCT00927238)
- Testing
- XL TDR, Lumbar fusion surgery
- Where
- 17 sites in United States
- Volunteers
- 246 people
- Sponsor
- NuVasive
Cervical Disc Disease
A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level
A multicenter, prospective, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in…
- Trial name
- NCT07287449
- Testing
- Triadyme-C
- Volunteers
- 164 people, healthy volunteers welcome
- Sponsor
- Dymicron
Glycogen Storage Disease Type II, Pompe Disease
A Study of the Safety and Pharmacokinetics of rhGAA in Siblings With Glycogen Storage Disease Type II
GSD-II (also known as Pompe disease) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA).
- Conditions
- Glycogen Storage Disease Type II, Pompe Disease, Acid Maltase Deficiency Disease, Glycogenosis 2
- Trial name
- NCT00051935
- Testing
- Alglucosidase alfa
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company
Fabry Disease
Replagal Enzyme Replacement Therapy for Children With Fabry Disease
Primary Objective(s): To assess the safety of Replagal at a dose of 0.2 mg/kg administered over 40 (+/-10) minutes in children with Fabry disease To assess the effect of Replagal on heart rate variability in patients 7 to 17…
- Trial name
- NCT00084084
- Testing
- Agalsidase alfa
- Where
- 14 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- Shire