Clinical trials: Medical Device Performance
Task Performance
Articulating Enseal Versus Ligasure Energy Devices
This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices.
- Trial name
- NCT02163538
- Testing
- articulating Enseal, Ligasure device
- Where
- 2 sites in United States
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- University of Louisville
Vascular Access Complications
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
- Trial name
- NCT01940354
- Testing
- AccuCath IV Catheter System, Conventional IV Catheter System
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
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
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
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
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
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
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
Injections, Intradermal
Performance and Safety Evaluation of an Intradermal Delivery Device
The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.
- Trial name
- NCT01359111
- Testing
- PATH ID Adapter
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- PATH
Upper Limb Amputation
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses.
- Trial name
- NCT02136238
- Testing
- Hosmer 5XA voluntary opening hook, TRS Grip 3 voluntary closing hook
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Catheterization Via a Femoral Sheath ≤ 6Fr
CaveoVasc System - a New Femoral Vascular Access and Closure Device
The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.
- Trial name
- NCT02694549
- Testing
- CaveoVasc
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- CaveoMed GmbH
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
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
Healthy Normals
Evaluation of Performance, Usability, and Reliability of a Novel Device for Continuous Collection of Physiological Data
Study objective: The primary objective of the clinical investigation is to evaluate the accuracy of BioStamp nPoint system algorithm measurements.
- Trial name
- NCT03257189
- Testing
- Physiological signal monitor, Heart rate and heart rate variability comparison device, Respiration rate comparison device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- MC10 Inc.
Visual Performance
Investigation of Ocular Signs & Symptoms in Wearers Fitted With Contact Lenses Following Digital Device Use
The objective of this study is to assess how various silicone hydrogel lenses perform when worn by subjects who are heavy digital device users.
- Trial name
- NCT02394756
- Testing
- Marketed Soft Contact lens, AIR OPTIX® AQUA, Biofinity®
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Vision Care, Inc.
Respiratory Failure
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
The purpose of this study is to compare if there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: exhibition-dialogued class and…
- Trial name
- LMANURSING (NCT01659268)
- Testing
- Simulation class, Exhibition-dialogued class
- Where
- Brazil
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
We Will Focus on Assessing the Clinical Performance of the BiliCare Device
Transcutaneous Bilirubinometry in Neonates With Bilicare System
The primary objective of this study is to define the performance evaluation of BiliCare TcB device to the "gold standard" bilirubin tests.
- Trial name
- NCT02372058
- Testing
- BiliCare
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Gerium Medical
Low Back Pain
Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies
The purpose of this study is to document the effectiveness of the Nimbus Multi-tined Expandable Electrode (MEE) Probe in carrying out the heating and ablation (cutting) of the small medial branch nerves that carry pain…
- Trial name
- NCT02120625
- Testing
- Lumbar MB RFN
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Nimbus Concepts, LLC
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
Device Validation of In-vivo Performance
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
- Trial name
- NCT06602804
- Testing
- Trima Accel Auto RBC Collection
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT