Clinical trials: Device Performance
- Condition Device Performance
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
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
Flanks Fat Reduction vs. Control
Fat Reduction in the Flanks Area vs. Control
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks.
- Trial name
- NCT02465775
- Testing
- UltraShape treatment
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Refractive Errors, Accomodation
Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
- Conditions
- Refractive Errors, Accomodation, Diagnostic Self Evaluation
- Trial name
- NCT04955379
- Testing
- EQ103
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Gastrointestinal Cancer
Endoscopic Nebulizing Device for Surgical Haemostatic-sealant Glubran® 2 Usability Trial in EMR and ESD
The aim of this single-center study is to evaluate the feasibility of the technique, usability and safety of the device ENDONEB.
- Trial name
- NCT06588881
- Testing
- nebulized application of the haemostatic surgical sealant after gastrointestinal endoscopic resection
- Where
- Italy
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- GEM SRL
Vital Signs
A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application
This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs.
- Trial name
- NCT03998098
- Testing
- Oxygen Saturation (Oximetry), Heart Rate (Pulse), Respiratory Rate
- Where
- United Kingdom
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Ultrasound Imaging of Anatomical Structures
A Study to Evaluate the Performance and Potential Benefits of an Assistive Artificial Intelligence Device ScanNav Anatomy Peripheral Nerve Block - US V1.0 for Ultrasound-guided Regional Anesthesia
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to provide data on the clinical performance of ScanNav Anatomy PNB for identification of anatomical structures during…
- Trial name
- NCT04918693
- Testing
- Ultrasound scanning
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- IntelligentUltrasound Limited
Unwanted Abdomen Fat
VelaShape and Contour I V3 for Abdominal Fat Reduction vs. Control
Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I V3 device for non-invasive fat reduction vs. control.
- Trial name
- NCT02553278
- Testing
- VelaShape device, Contour I V3 device
- Where
- Israel
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Syneron Medical
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
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
Sleep Apnea
Evaluation of Compumedics "Somfit" Device
To study whether Somfit is substantially equivalent to an existing approved device (i.e. Compumedic's Grael System) to assist in elucidating sleep disorders.
- Trial name
- NCT04326127
- Testing
- Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)
- Where
- Australia
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Compumedics Limited
Over Weight, Obesity
Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
- Trial name
- NCT01753609
- Testing
- Tulip capsule
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Tulip Medical Ltd.
Measurement of Diathermy on Anatomical Locations of the Body
Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine Devices with commercially available ultrasound gel coupling patches.
- Trial name
- NCT05259995
- Testing
- Sustained Acoustic Medicine
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- ZetrOZ, 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
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Healthy Adult Participants
A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.
- Trial name
- NCT06208488
- Testing
- Gefurulimab PFS-SD, Gefurulimab AI
- Where
- 2 sites in Canada
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Physical Rehabilitation
Performance of the BioGaming Device (YuGo) in the Support of Physical Rehabilitation
The purpose of this study is to evaluate the movements performed according to the BioGaming YuGo software, and verify that they are rehabilitation movements.
- Trial name
- NCT02373748
- Testing
- BioGaming YuGo System
- Where
- Israel
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- BioGaming Ltd.
Blood Routine Examination
Performance Evaluation of In-Vitro Diagnostic Device
This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical Chemistry Analyzer.
- Trial name
- NCT02894762
- Where
- Taiwan
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Lite-On Technology Corporation H.S.P.B
Contraception
IUB(TM) SCu300B - Post Marketing Performance Study in Austria
Participating investigators will locate all IUB B insertions conducted at their facility at least 12 month prior the initiation of study data collection. The study is composed of 2 parts.
- Trial name
- NCT02778061
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.