Clinical trials: Instrumentation
Arthritis, Osteoarthritis
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
A total knee replacement is the removal of parts of the knee joint, that have become damaged due to osteoarthritis, and replacing these with artificial implants.
- Conditions
- Arthritis, Osteoarthritis, Knee, Joint Diseases
- Trial name
- NCT04976972
- Testing
- NAVIO/CORI Surgical System, Non-robotic conventional instrumentation
- Where
- 10 sites in Ireland, United Kingdom
- Sponsor
- Smith & Nephew Orthopaedics AG
Corneal Transplantation
Corneal Endothelium Delivery Instrument
The purpose of this study is to determine whether the surgical outcomes in patients undergoing Descemet's Stripping Endothelial Keratoplasty (DSEK) are improved with the use of an insertion device over the traditional forceps…
- Trial name
- NCT00874835
- Testing
- EndoSaver™ Corneal Endothelium Delivery Instrument
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Ocular Systems, Inc.
Hearing Loss
A Comparative Clinical Investigation of Two Hearing Instrument Digital Signal Processing
The purpose of this study is to show that the performance of the new digital signal processing system is better than the system used in the currently CE marked devices.
- Trial name
- NCT04374851
- Testing
- Polaris miniRITE BTE, Viron miniRiTE BTE
- Where
- Switzerland
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Bernafon AG
Peripheral Arterial Disease
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Lower Extremity Arteriosclerosis Occlusive Lumen
This trial was a prospective, multicenter, single-group design. To undergo endovascular treatment of lower extremity arteriosclerosis obliterans After the subjects were selected and enrolled, the surgeons used the endovascular…
- Trial name
- NCT05625711
- Testing
- The endovascular interventional surgical instrument control system
- Volunteers
- 260 people
- Sponsor
- Shanghai Operation Robot Co., Ltd.
Anemia
A Clinical Evaluation of the OrSense Non-invasive Blood Hb/Hct Measurement Instrument, the Hemo-Monitor NBM200/MP
The purpose of the study is to define the precision, accuracy and variability of the NBM-200 system in non invasive blood Hemoglobin (Hb) measurements relative to the laboratory blood analyzer by comparing two consecutive Hb…
- Trial name
- NCT01915953
- Where
- Israel
- Volunteers
- 500 people
- Sponsor
- OrSense, Ltd.
Lumbar or Thoraco-lumbar Adult Deformity
Sagittal Plane Correction With Pass-LP Device in Adult Deformity Patients
The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP…
- Trial name
- NCT01635322
- Testing
- Polyaxial posterior spinal fusion system
- Where
- 2 sites in United States, France
- Volunteers
- 54 people
- Sponsor
- Medicrea International
Multiple Sclerosis, Relapsing-Remitting
An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy
Significant data from placebo-controlled clinical trials have demonstrated the efficacy of Rebif in relapsing remitting multiple sclerosis (RRMS) with reduction in relapse rate, delay in disability progression, and reduction in…
- Trial name
- COMPARE (NCT01141751)
- Volunteers
- 334 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Rotator Cuff Tears of the Shoulder, Labrum Injury
Lok™ Suture Anchors Safety & Performance Trial
The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation).
- Trial name
- NCT07448584
- Testing
- Rotator cuff lesions repair combined to a long head of biceps pathology, PASTA lesion, Shoulder instability repair
- Where
- France
- Volunteers
- 216 people
- Sponsor
- Move Up SAS
Osteoarthritis, Knee
Oxford Partial Knee Comparative Instrument Pilot Study
The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Oxford Partial Knee System using Signature Custom Guides and Conventional Instrumentation.
- Trial name
- NCT01410786
- Testing
- Conventional Instrumentation, Signature Custom Guides
- Where
- New Zealand
- Volunteers
- 35 people
- Sponsor
- Zimmer Biomet
Diabetes Mellitus, Kidney Diseases
Evaluation of the Analytical Performance of ALLEGRO™ Instrument
To assess the performance of the Allegro in the hands of CLIA-Waived Point-of-Care users in at least three distinct Point-of-Care clinical settings and compare the performance characteristics to other accepted Point-of-Care…
- Conditions
- Diabetes Mellitus, Kidney Diseases, Metabolic Disease
- Trial name
- NCT04096313
- Testing
- HbA1c, Lipids, UACR
- Where
- 3 sites in United States
- Volunteers
- 628 people, healthy volunteers welcome
- Sponsor
- Nova Biomedical
Staphylococcal Vaccine
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of…
- Trial name
- STRIVE (NCT02388165)
- Testing
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
- Where
- 301 sites in United States, Austria and 9 more
- Volunteers
- 3,450 people
- Sponsor
- Pfizer
Osteoarthritis, Knee
Persona TKA With iASSIST Knee System and iASSIST Knee System
The purpose of this study is to compare the accuracy of knee component alignment between patients operated with iASSIST Knee (Investigational group) versus patients operated without iASSIST Knee (Control group) using the same…
- Trial name
- NCT03227692
- Testing
- Persona Knee System, Total Knee Arthroplasty, iAssist Knee
- Where
- 3 sites in Japan
- Volunteers
- 93 people
- Sponsor
- Zimmer Biomet
Healthy
A Clinical Evaluation of the Next Generation Diagnostic Instrument (NGDI)
The purpose of this study is to measure the aberrations, corneal surface topography and pachymetry of normal human eyes with the NGDI.
- Trial name
- NCT00347594
- Testing
- Next Generation Diagnostic Instrument (NGDI), Zyoptix Diagnostic Workstation (ZDW)
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Severe Knee Pain, Severe Knee Disability
Persona Revision Knee System EMEA PMCF Study
The purpose of this post-market clinical follow-up study is to confirm the long-term safety, performance and clinical benefits of the Persona Revision Knee System Implants and Instrumentation in revision Total Knee Arthroplasty.
- Conditions
- Severe Knee Pain, Severe Knee Disability, Revision Arthroplasty
- Trial name
- NCT07843966
- Where
- 2 sites in Denmark, Spain
- Volunteers
- 238 people
- Sponsor
- Zimmer, GmbH
Pathology
Instrument Precision Study for Validation of PIPS 5.1
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system.
- Trial name
- NCT04879056
- Testing
- PIPS 5.1
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Hydrocephalus
Guided Application of Ventricular Catheters
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can…
- Trial name
- GAVCA (NCT01811589)
- Testing
- Thomale-Guide, Free-hand
- Where
- 9 sites in Germany
- Volunteers
- 144 people
- Sponsor
- Aesculap AG
Degenerative Disc Disease
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied…
- Trial name
- NCT03438747
- Testing
- P-15L Bone Graft, Local autologous bone in a TLIF with Instrumentation
- Where
- 34 sites in United States
- Volunteers
- 290 people
- Sponsor
- CeraPedics, Inc
Percutaneous Coronary Intervention, Coronary Heart Disease
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system （ALLVAS®robot）and supporting consumables for coronary artery interventional surgery.
- Conditions
- Percutaneous Coronary Intervention, Coronary Heart Disease, Robotic Surgical Procedures
- Trial name
- NCT05642286
- Testing
- ALLVAS® robotic-assisted PCI
- Volunteers
- 218 people
- Sponsor
- Shanghai Operation Robot Co., Ltd.
Proximal Humeral Fracture, Proximal Tibia Fractures
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
The study is a monocentric, retro- and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the Zimmer® Plates…
- Conditions
- Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
- Trial name
- NCT05215613
- Where
- Italy
- Volunteers
- 57 people
- Sponsor
- Zimmer Biomet
Diabetes
Study of the Analytical Performance of ALLEGRO™ Instrument
A new analyser has been developed (Allegro™) which allows the tests to be undertaken at the clinic, with the results available in a few minutes.
- Trial name
- NCT04035044
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Nova Biomedical