Clinical trials: Device Replacement
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
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
Total Hip Replacement System
Ceramic on Metal Total Hip Replacement System Multi-Center,Investigational Device Exemption Clinical Trial
The purpose of this study is to demonstrate non-inferiority of the Ceramic on Metal Total Hip when compared to a TRANSCEND® historical control group of patients with primary total hip replacement.
- Trial name
- COM (NCT00820443)
- Testing
- Ceramic on metal prosthesis
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- MicroPort Orthopedics Inc.
End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis
Human Factors Validation Testing for the Peripal System; a Manual Connection Assist Device for Peritoneal Dialysis Devices
It is estimated that there are currently over 3 million patients receiving dialysis treatment worldwide. With effective pre-dialysis counselling, a majority of patients choose the home-based therapy peritoneal dialysis (PD) but…
- Conditions
- End Stage Renal Failure on Dialysis, End Stage Renal Disease on Dialysis, Renal Failure, Peritoneal Dialysis
- Trial name
- NCT04292210
- Testing
- Perisafe
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Peripal AG
Mitral Valve Disease, Mitral Valve Stenosis
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance.
- Conditions
- Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
- Trial name
- FOLDAX (NCT04717570)
- Testing
- Foldax TRIA Mitral Valve
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Foldax, Inc
Degenerative Disc Disease, Chronic Low-back Pain
Post Market Observational Trial for the PerQdisc Nucleus Replacement Device
PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.
- Trial name
- PMCF1 (NCT05105490)
- Testing
- PerQdisc
- Where
- Germany
- Sponsor
- Spinal Stabilization Technologies
Cerebral Embolicprotection Device, TAVR
Cerebral Embolic Protection Device During TAVR
To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve…
- Trial name
- NCT07627984
- Testing
- Cerebral embolic protection device
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, 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
Arthroplasty, Knee Replacement, Wound Healing
Zip® Surgical Skin Closure Device vs. Staples for Skin Closure in Subjects Having Undergone Bilateral Knee Arthroplasty
Study designed to compare the Zip Surgical Skin Closure device vs. conventional staples for wound closure following bi lateral knee replacement surgery.
- Trial name
- NCT02460172
- Testing
- Zip Surgical Skin Closure, Steel Staples
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- ZipLine Medical Inc.
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.