Clinical trials: Device Replacement, open to volunteers
- Condition Device Replacement
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
Aortic Valve Stenosis, Aortic Stenosis
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement…
- Conditions
- Aortic Valve Stenosis, Aortic Stenosis, Aortic Valve Disease
- Trial name
- NCT07276711
- Testing
- EmStop Embolic Protection System, Boston Scientific Sentinel
- Where
- 7 sites in United States
- Volunteers
- 663 people
- Sponsor
- EmStop Inc
Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.
- Conditions
- Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle, Talar Dysfunction
- Trial name
- NCT06311331
- Testing
- Total Talus Replacement (TTR)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Restor3D
Arthroplasty, Hip, Replacement
Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
- Trial name
- NCT05044767
- Testing
- total hip arthroplasty
- Where
- 13 sites in France
- Volunteers
- 4,500 people
- Sponsor
- ATF Implants
Aortic Aneurysm, Aortic Aneurysm and Dissection
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic
- Trial name
- RAPID (NCT07078383)
- Testing
- Rapidlink
- Where
- 21 sites in United States, Austria and 3 more
- Volunteers
- 150 people
- Sponsor
- Vascutek Ltd.
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.
Tricuspid Valve Regurgitation, Heart Valve Diseases
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
- Conditions
- Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases
- Trial name
- NCT06569602
- Testing
- Transcatheter Tricuspid Valve Replacement
- Where
- 23 sites in Germany, Greece and 4 more
- Volunteers
- 500 people
- Sponsor
- Edwards Lifesciences
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
Acute Kidney Injury
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI)…
- Trial name
- NEUTRALIZE-AKI (NCT05758077)
- Testing
- Selective Cytopheretic Device, Standard of Care
- Where
- 36 sites in United States
- Volunteers
- 339 people
- Sponsor
- SeaStar Medical
Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Trial name
- GUARDIAN (NCT06962371)
- Testing
- cerebral embolic protection
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- Transverse Medical, Inc.
Knee Osteoarthritis
MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar Design
The purpose of this investigational device exemption (IDE) study is to monitor the performance (safety and efficacy) of the Maxx Orthopedics, Freedom Total Knee® System, with a femoral component of similar design, manufactured…
- Trial name
- NCT06627673
- Testing
- Total Knee Arthroplasty
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- Maxx Orthopedics Inc
Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis
Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty
This long-term outcomes study is designed to collect safety and efficacy data on designated, commercially available, hip arthroplasty products.
- Conditions
- Hip Replacement, Primary, Secondary or Post-traumatic Osteoarthrosis, Femur Head Necrosis, Congenital Dislocations
- Trial name
- NCT02230826
- Where
- 13 sites in France
- Volunteers
- 2,500 people
- Sponsor
- Corin
Urinary Urge Incontinence
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
- Trial name
- NCT07383688
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neuspera Medical, Inc.