Clinical trials: Replacement
Tobacco Use Disorder, Smoking
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
Study to determine the safety and effectiveness of silver salt in Ariva® Silver Wintergreen Lozenge on discouraging smoking, by its imparting an unfavorable taste to the smoker when tobacco is smoked.
- Trial name
- NCT01337817
- Testing
- Ariva Silver Wintergreen, Ariva Wintergreen
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Star Scientific, Inc
Venous Thromboembolism
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee replacement [TKR] surgery.
- Trial name
- TREK (NCT00331838)
- Testing
- Semuloparin sodium, Enoxaparin sodium
- Where
- 19 sites in Argentina, Bulgaria and 17 more
- Volunteers
- 705 people
- Sponsor
- Sanofi
Arthroplasty, Replacement
INHANCE Stemless Reverse Shoulder IDE
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
- Conditions
- Arthroplasty, Replacement, Shoulder
- Trial name
- NCT06323980
- Testing
- Reverse Total Shoulder
- Where
- 15 sites in United States
- Volunteers
- 168 people
- Sponsor
- DePuy Orthopaedics
Cervical Disc Disease
A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease
This study will be a non-randomized trial consisting of patients with single level (C3 to C7) symptomatic cervical disc disease who have not previously received fusion surgery at the same level, and have failed to improve with…
- Trial name
- CerPass (NCT01433367)
- Testing
- CerPass® Total Disc Replacement
- Where
- Mexico
- Volunteers
- 2 people
- Sponsor
- NuVasive
Aortic Valve Stenosis
Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
- Trial name
- CAPTURE-1 (NCT06103591)
- Testing
- The EmStop Embolic Protection System (EmStop System)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- EmStop Inc
Osteoarthritis
Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System
This post-marketing investigation will evaluate the functional knee performance of Subjects who have undergone primary total knee arthroplasty (TKA).
- Trial name
- 10004 (NCT01746524)
- Testing
- ATTUNE Primary Total Knee Arthroplasty
- Where
- 20 sites in United States, Australia and 2 more
- Volunteers
- 1,138 people
- Sponsor
- DePuy Orthopaedics
Growth Hormone Deficiency (GHD)
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis.
- Trial name
- NCT01947907
- Testing
- ACP-001, Human Growth Hormone
- Where
- 36 sites in Belarus, Bulgaria and 12 more
- Volunteers
- 53 people
- Sponsor
- Ascendis Pharma A/S
Hip Disease
ACE Acetabular Cup Spanish PMCF Study
A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, involving the replacement of both the hip ball and socket.
- Trial name
- NCT07115732
- Testing
- Total Hip Replacement
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- JRI Orthopaedics
Knee Osteoarthritis
The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly
The primary objective of this investigation was to evaluate \& compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.
- Trial name
- NCT00733928
- Testing
- PFC Sigma knee with all-poly tibial component, PFC Sigma knee with metal backed tibia
- Where
- United Kingdom
- Volunteers
- 67 people
- Sponsor
- DePuy International
Osteoarthritis
DSJ-2016-07 ATTUNE® Cementless CR RP Japan
The primary objective is to investigate the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE® primary, cementless TKA RP system as measured with the KOOS questionnaire…
- Trial name
- NCT03193034
- Testing
- Cementless Total Knee Arthroplasty
- Where
- 4 sites in Japan
- Volunteers
- 81 people
- Sponsor
- DePuy Orthopaedics
Unilateral Cataract Extraction, Congenital Cataract
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in…
- Trial name
- ILR7 (NCT02132312)
- Testing
- OMS302, Phenylephrine HCl
- Where
- 11 sites in United States
- Volunteers
- 78 people
- Sponsor
- Omeros Corporation
Osteoarthritis
Standard Total Knee Arthroplasty Using Platelet Rich Plasma (PRP)
Clinical study to determine if there is a difference in hemoglobin level between patients undergoing total knee arthroplasty with and without platelet-rich plasma.
- Trial name
- NCT01075230
- Testing
- Total knee arthroplasty
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Exactech
Mitral Valve Regurgitation
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.
Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.
- Trial name
- APOLLO (NCT03242642)
- Testing
- Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
- Where
- 85 sites in United States, Canada and 1 more
- Volunteers
- 1,056 people
- Sponsor
- Medtronic Cardiovascular
Hypogonadism
Subcutaneous Testosterone Replacement Efficacy and Safety in Adult Men Diagnosed With Hypogonadism
Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector
- Trial name
- STEADY (NCT02159469)
- Testing
- Testosterone enanthate auto-injector
- Where
- 28 sites in United States
- Volunteers
- 150 people
- Sponsor
- Antares Pharma Inc.
Arthroplasty, Replacement, Knee
Scorpio NRG (eNeRGize) Cruciate Retaining (CR) Post-market International Outcome Study
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
- Trial name
- Scorpio NRG (NCT02524730)
- Testing
- Primary total knee replacement (Scorpio NRG CR Total Knee System)
- Where
- 5 sites in Austria, Germany and 2 more
- Volunteers
- 205 people
- Sponsor
- Stryker Orthopaedics
Postoperative Pain
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative…
- Trial name
- NCT00403234
- Testing
- Buprenorphine transdermal patch
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Purdue Pharma LP
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
Mitral Regurgitation
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement
Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
- Trial name
- EMBRACE (NCT07409285)
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- HighLife SAS
Arthroplasty, Replacement, Knee, Venous Thrombosis
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism…
- Trial name
- NCT00246025
- Testing
- Dabigatran etexilate
- Where
- 38 sites in Japan
- Volunteers
- 512 people
- Sponsor
- Boehringer Ingelheim
Venous Thromboembolism
A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants
The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin The secondary objectives of the…
- Trial name
- NCT05618808
- Testing
- REGN9933, Enoxaparin, Apixiban
- Where
- 16 sites in Belgium, Bulgaria and 5 more
- Volunteers
- 373 people
- Sponsor
- Regeneron Pharmaceuticals