Clinical trials: Instrumentation
- Condition Instrumentation
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Acquired Immunodeficiency Syndrome
Accuracy Evaluation of the BD FACS Presto System
The enumeration of T lymphocytes positive for the CD4 antigen is used to determine the immune status of patients with, or suspected of developing, immune deficiencies such as AIDS.
- Trial name
- NCT02396355
- Testing
- Investigational BD FACSPresto System, BD FACSCalibur flow cytometer, Sysmex hematology analyzer KX-21
- Where
- 6 sites in United States, India and 2 more
- Volunteers
- 583 people
- Sponsor
- Becton, Dickinson and Company
Dystrophic Epidermolysis Bullosa
Prospective, Longitudinal Natural History Study in Dystrophic Epidermolysis Bullosa
The objective of this study is to characterize the extent and severity of disease in subjects with DEB and the progression of disease over a timeframe relevant to interventional studies.
- Trial name
- NCT01768026
- Where
- United States
- Sponsor
- Lotus Tissue Repair, Inc.
Idiopathic Scoliosis
Scoliosis Surgery Using the PASS® LP System
The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the…
- Trial name
- NCT01019109
- Testing
- Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
- Where
- 3 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medicrea, USA Corp.
G6PD, G6PD Deficiency
Comparative Evaluation of the FINDER Instrument and FINDER G6PD Cartridge in Adults and Neonates
A prospective clinical study to compare the clinical performance of the FINDER™ Instrument and the G6PD assay to an FDA cleared instrument/reagent combination in adult and neonate populations.
- Trial name
- NCT04146246
- Testing
- G6PD assay
- Where
- 3 sites in United States
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Baebies, Inc.
Degenerative Spine Disease, Spinal Deformity
Prospective, Observational Registry of Renaissance-guided Spine Surgeries
To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
- Trial name
- NCT02212899
- Where
- 4 sites in United States
- Volunteers
- 93 people
- Sponsor
- Mazor Robotics
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Degenerative Arthritis of Knee
Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched…
- Trial name
- NCT01084772
- Testing
- VISIONAIRE Total Knee Arthroplasty, Standard Total Knee Arthroplasty
- Where
- 7 sites in United States, Australia
- Volunteers
- 134 people
- Sponsor
- Smith & Nephew, Inc.
Influenza A, Influenza Type B
FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both…
- Conditions
- Influenza A, Influenza Type B, SARS CoV 2 Infection, RSV Infection
- Trial name
- NCT05928507
- Testing
- Diagnostic Test for identification of influenzas A, influenzas B, RSV and SARS-CoV-2 infections
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- Baebies, Inc.
Congenital Thrombotic Thrombocytopenic Purpura
Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]
The purpose of this study is to assess the psychometric properties of a recently developed congenital thrombotic thrombocytopenic purpura (cTTP)-specific patient-reported outcomes (PRO) instrument.
- Trial name
- NCT03519672
- Testing
- No intervention
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 41 people
- Sponsor
- Baxalta now part of Shire
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Hydrocephalus Shunt (proGAV) Requiring Adjustment
X-Ray Verified Accuracy of the proGAV Verification Instrument
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.
- Trial name
- X-AMIN (NCT01885468)
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Aesculap, Inc.
Blood Pressure
ModPG3 Adult/Ped ISO 81060-2:2018 Study Protocol
Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today.
- Trial name
- NCT05654714
- Testing
- ModPG3 Investigational Device, Auscultatory Equipment
- Where
- Italy
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Welch Allyn
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
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
Distal Radius Fracture, Distal Ulna Fracture
PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System
The study is a single-center, retrospective, 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 DVR Plates.
- Conditions
- Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
- Trial name
- NCT04653051
- Where
- United Kingdom
- Volunteers
- 111 people
- Sponsor
- Zimmer Biomet
Asthma
Instrument Utility for Suspected Asthma (0000-042)(COMPLETED)
This research study was designed to help improve the diagnosis and treatment of asthma in young children. An interventional strategy using a scoring system based on risk factors and symptoms/episodes was tested to determine its…
- Trial name
- NCT00211575
- Testing
- Disease Management Assessment
- Volunteers
- 400 people
- Sponsor
- Merck Sharp & Dohme LLC
Viral Respiratory Infection
Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs
The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to…
- Trial name
- NCT01806285
- Volunteers
- 205 people
- Sponsor
- GenMark Diagnostics