Clinical trials: Medical Device Performance
Hyperglycemia
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.
- Trial name
- MAHI (NCT01763567)
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Medtronic MiniMed, Inc.
Hepatic Disease, Renal Disease
Assess Safety and Performance of the Kronos Electrocautery Device for Electrocautery Procedures Following Coaxial Biopsy Procedures
The primary objective for this study is to assess safety and performance of the Kronos Electrocautery Device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver…
- Trial name
- NCT05593211
- Testing
- Kronos Electrocautery Device
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Single Pass Inc
Polyp, Colorectal
Colorectal Polyp Clinical Decision Support Device Study
The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.
- Conditions
- Polyp, Colorectal, Colonoscopy
- Trial name
- CDSD (NCT04437615)
- Testing
- Colonoscopy, Clinical Decision Support Device
- Where
- United States
- Volunteers
- 2,379 people
- Sponsor
- Olympus Corporation of the Americas
Tachyarrhythmias, Heart Failure
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00526162
- Testing
- Bi-ventricular Implantable Cardioverter Defibrillator
- Where
- Germany
- Volunteers
- 83 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Performance Study of the Harpoon Mitral Valve Repair System
The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- NCT03285724
- Testing
- Harpoon Artificial ePTFE Chords
- Where
- 2 sites in Poland
- Volunteers
- 1 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation, Mitral Valve Prolapse
Safety and Early Feasibility Study of the Harpoon Medical Device (EFS)
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant advantages over current surgical interventions including: 1) a small minimally…
- Conditions
- Mitral Valve Regurgitation, Mitral Valve Prolapse, Mitral Valve Insufficiency
- Trial name
- EFS (NCT02771275)
- Testing
- Harpoon Medical Device
- Where
- 2 sites in Poland
- Volunteers
- 13 people
- Sponsor
- Edwards Lifesciences
Knee Arthroplasty
Active Versus Passive Motion Device Following Knee Replacement Surgery
The purpose of this study is to determine how well an active motion device, Camoped, works compared to a continuous passive motion device, CPM, for rehabilitation after partial or total knee replacement.
- Trial name
- NCT02339831
- Testing
- CAMOPED, CPM passive motion device
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
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
Iliac Crest Harvesting Procedure-Bone Void Filler
Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures
The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where bone was removed or "harvested") for the back surgery. The study will be focusing on patients who require back surgery.
- Trial name
- NCT00837473
- Testing
- Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Osteotech, Inc
Symptomatic Femoro-popliteal Chronic Total Occlusion
The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)
This is a prospective, multicenter, randomized, single-blind study enrolling up to 75 subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO will be randomized 2:1 to treatment with the…
- Trial name
- NCT02145299
- Testing
- TruePath CTO Device, CROSSER CTO Device
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Yale University
Pulmonary Arterial Hypertension
Nitric Oxide, GeNO Nitrosyl Delivery System
The primary aim of the study is to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during RHC.
- Trial name
- NCT01165047
- Testing
- Nitric Oxide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Wake Forest University Health Sciences
Anesthesia
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
- Trial name
- NCT03865316
- Testing
- SedLine Vs Comparator Test Group
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Masimo Corporation
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Transcutaneous Bilirubinometry in Neonates With the BiliCare System Compared to the Invasive TSB Test
The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
- Trial name
- NCT02372071
- Testing
- BiliCare
- Where
- Israel
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Gerium Medical
Thoracic Diseases
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine…
- Trial name
- SURPASS (NCT03286400)
- Testing
- CTAG Device with ACTIVE CONTROL
- Where
- 20 sites in France, Germany and 5 more
- Volunteers
- 127 people
- Sponsor
- W.L.Gore & Associates
Myopia
Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial…
- Trial name
- FOX (NCT06308666)
- Testing
- Delefilcon A contact lenses
- Where
- Canada
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- University of Waterloo
Myopia
Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who identify themselves as heavy digital devices…
- Trial name
- PUG (NCT04201639)
- Testing
- Verofilcon A contact lenses
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Waterloo
Skin Neoplasms
Safety and Performance Evaluation of the Topical Hemostatic Device (AC5™) Following Excision of Skin Lesions
This study is designed to monitor patient safety after excision of skin lesions and subsequent application of AC5 topical hemostatic agent and to assess the performance of AC5 for controlling bleeding in skin wounds.
- Trial name
- NCT02704104
- Testing
- AC5 Topical Hemostatic Device
- Where
- Ireland
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Arch Therapeutics
Wounds
Simplified Negative Pressure Wound Therapy
The objective of this study is to implement a simplified Negative Pressure Wound Therapy (sNPWT) device in a low resource setting.
- Trial name
- NCT01339429
- Testing
- simplified negative pressure wound therapy device (Wound Pump device)
- Where
- 2 sites in Rwanda
- Volunteers
- 41 people
- Sponsor
- Brigham and Women's Hospital
Hypothermia
Intraoperative Warming Comparison of Devices
Hypothermia is a common and serious complication during anesthesia and surgery. Anesthetic-induced hypothermia results from the inhibition of thermoregulatory control and exposure to cold operating room environment.
- Trial name
- NCT00650260
- Testing
- Dynatherm Medical vitalHEAT Temperature Management System vH2, Bair Hugger™ (Arizant Healthcare, Eden Prairie, MN)
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- University of South Florida