Clinical trials: Medical Device Performance
No Disease or Condition is Being Studied
Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma
Study Design After the eligibility assessment during screening and obtaining a written informed consent form, the volunteers' demographic information and medical history will be recorded.
- Trial name
- PRP (NCT07041918)
- Testing
- The study is entirely designed to analyze product performance (analyze only results from whole blood and derived from the PRP tubes), and no interventions will be performed.
- Where
- Turkey (Türkiye)
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Disera Tıbbi Cihazlar Lojistik Sanayi ve Ticaret A.Ş
Aging
Evaluation of Anti-aging Performance and Tolerance of a Hyaluronic Acid-based Filler NCTF135HA®
The NCTF135HA medical device from Laboratoires FILL-MED by FILORGA Company is an injectable solution for the treatment of wrinkles and biorevitalization of injected mature skin using a multi-injection technique with CE marking.
- Trial name
- HEBE2 (NCT05609617)
- Testing
- injection, Cream application
- Where
- France
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Laboratoires FILLMED
Ultrasound Imaging of Anatomical Structures
Clinical Performance Study: Evaluate Scanning & Interpretation Performance With & Without ScanNav Anatomy PNB
This is a single-centre, randomised, interventional prospective cohort study to be undertaken at offices of Intelligent Ultrasound Limited in Cardiff, United Kingdom.
- Trial name
- PNB (NCT05156099)
- Testing
- Ultrasound Scanning, Ultrasound Scanning - 2 months later
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- IntelligentUltrasound Limited
Carbohydrate, Caffeine
Carbohydrate Rinsing and Caffeine Gum on Performance of Romanian Deadlifts Performance
Two experiments were completed to investigate the effects of carbohydrate mouth rinsing and caffeine gum chewing on inertial resistance exercise performance.
- Trial name
- NCT05900349
- Testing
- Carbohydrate mouth rinsing, 200 mg caffeine gum
- Where
- Taiwan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Taiwan Sport University
Visual Function
A Performance Study Comparing the EyeMirage (Test Device) to Standard of Care (Reference Device) in Patients 18 to 65 Years of Age Undergoing Standard Eye Examinations Such as Visual Acuity, Visual Field, Color Vision, and Self-Paced Saccade for Various Conditions
This study will assess the effectiveness and accuracy of results of a new device for eye function testing. This will be done by comparing results of four eye tests that are done through the current standard used in eye clinics…
- Trial name
- NCT06908967
- Testing
- EyeMirage device
- Where
- 4 sites in Canada
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Neuroptek Corporation Inc.
HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus)
MAGIA H3S Point of Care Test Performance for HIV, HBV, HCV, and Syphilis Screening in Pregnant Women in DR Congo
Performance study to evaluate the clinical performance of the In-Vitro Diagnostic Medical Device MagIA H3S (a Multiplex Point-of-Care test for the combined detection of Human Immunodeficiency Virus (HIV), Hepatitis B and C and…
- Conditions
- HIV - Human Immunodeficiency Virus, HBV (Hepatitis B Virus), Hepatitis C Virus (HCV), Syphilis
- Trial name
- MAGICS MAM (NCT07388979)
- Testing
- MAGIA H3S
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Gardiens de Vies
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.
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
COVID-19
Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.
The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).
- Trial name
- NCT05094674
- Testing
- Breath Sample analysis
- Where
- United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Tera Group
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.
Chronic Heart Failure
Effect of Enhanced Sweat Rate on the Safety and Edema Status of Chronic Edematous Patients
The purpose of this study is to demonstrate safety and performance of AquaPass System for enhancing fluid transfer through the skin, by increased sweat rate, in edematous patients.
- Trial name
- NCT04578353
- Testing
- The AquaPass System
- Where
- Israel
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- AquaPass Medical Ltd.
Large Hole Percutaneous Venous Closure
PerQseal® Elite Venous Clinical Study (ELITE-Venous)
The objective of this study is to evaluate the safety and effectiveness of the PerQseal Elite vascular closure system when used to achieve haemostasis of common femoral venotomies created by 14 to 22F sheaths (venotomy up to 26F)…
- Trial name
- ELITE-Venous (NCT06007339)
- Testing
- PerQseal ELITE
- Where
- Netherlands
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Vivasure Medical Limited
Obstetric Anal Sphincter Injury, Delivery Complication
Detection of Obstetric Anal Sphincter Injuries With ONIRY Device
The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries.
- Conditions
- Obstetric Anal Sphincter Injury, Delivery Complication, Obstetric Complication
- Trial name
- NCT04903977
- Testing
- Laboratory tests: blood and faeces tests, Gynaecological and proctological examinations, 3-D Endoanal Ultrasound
- Where
- 5 sites in Czechia, Poland and 2 more
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- OASIS Diagnostics S.A.
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.
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
Stoma Ileostomy
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device.
- Trial name
- NCT03784989
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Heart Failure，Congestive
Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™
AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.
- Trial name
- NCT03751904
- Testing
- AcoustiCare
- Volunteers
- healthy volunteers welcome
- Sponsor
- Signature Medical, Inc.
Intubation; Difficult or Failed
Use of Alexa as a Cognitive Aid for Emergency Front Of Neck Access (FONA)
The aim of the study is to investigate whether a voice activated cognitive aid can improve performance in a simulated emergency front-of-neck access scenario.
- Trial name
- FONA-A (NCT05635773)
- Testing
- Use of Alexa Visual Cognitive aid
- Where
- United Kingdom
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Excess Abdominal Fat
UltraShape Power Device for Fat Reduction in Flanks
Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.
- Trial name
- NCT03502473
- Testing
- UltraShape Power device
- Where
- Israel
- Volunteers
- healthy volunteers welcome
- Sponsor
- Syneron Medical
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