Clinical trials: Device Performance
Nasal Dryness
Evaluation of a Medical Device Based on Isotonic Seawater and Hyaluronic Acid Used as a Nasal Spray
The purpose of this study is to see whether the nasal spray can help improve hydration of the nasal mucosa, reduce discomfort linked to nasal dryness, and confirm its safety in patients suffering from nasal dryness.
- Trial name
- NCT07204158
- Testing
- Spray pompe nasal confort
- Where
- France
- Sponsor
- YSLab
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
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
Hypothermia
Clinical Performance of the Embrace Isothermal Mattress
The purpose of this pilot study is to evaluate the performance of a new warming technology (Embrace Isothermal Mattress) during the thermal weaning of premature infants from incubators to open cribs.
- Trial name
- KBW (NCT01425086)
- Testing
- Embrace, PCM, warming blanket
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Stanford University
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Evaluation of the GlucoTrack, Non-Invasive Glucose Monitoring Device
The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels
- Conditions
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Gestational Diabetes
- Trial name
- NCT00433758
- Testing
- GlucoTrack
- Where
- Israel
- Volunteers
- 142 people
- Sponsor
- Integrity Applications Ltd.
Diabetes Mellitus
Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report
The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used…
- Trial name
- NCT02910674
- Testing
- Dario Blood Glucose Monitoring System
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- LabStyle Innovations Ltd.
Blindness
Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light…
- Trial name
- NCT04725760
- Testing
- BrainPort Vision Pro
- Where
- 7 sites in France
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Wicab
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG
Hydrocephalus, Hydrocephalus in Children
A Study Evaluate Aqueduct's Smart External Drain
To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically: Number, type and duration of staff interactions.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, Tumor, Brain
- Trial name
- SED (NCT03113799)
- Testing
- Smart External Drain - SED
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Aqueduct Critical Care
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
Sarcoma, Intracranial Neoplasm
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's…
- Conditions
- Sarcoma, Intracranial Neoplasm, Pelvic Bone Neoplasm
- Trial name
- NCT06291662
- Testing
- 3D printer applications
- Where
- 3 sites in Italy
- Volunteers
- 12 people
- Sponsor
- Kathleen McGreevy
Strongyloides Stercoralis Infection, Device Performance
Evaluation of the Rapid Diagnostic Test SsRT+ for Strongyloides Stercoralis
The goal of this performance study is to determine if the diagnostic accuracy of the SsRT+ for the diagnosis of S. stercoralis infection meets the minimum requirements defined in the WHO target product profile.
- Conditions
- Strongyloides Stercoralis Infection, Device Performance, Diagnostic
- Trial name
- NCT07876622
- Testing
- Analysis of serum samples using two in vitro diagnostic devices (SsRT+ and Ss Rapid)
- Where
- Italy
- Volunteers
- 780 people
- Sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
Uterine Bleeding Profile Prediction
A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)
Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods.
- Trial name
- MyIUS (NCT04989595)
- Testing
- MyIUS app
- Where
- 6 sites in Brazil, Denmark and 4 more
- Volunteers
- 3,045 people, healthy volunteers welcome
- Sponsor
- Bayer
Diabetes Mellitus
CareLink Connect - Technical Evaluation Study
The purpose of this study is to evaluate the performance, patient satisfaction and safety of connectivity gateway device CareLink Connect, transferring CGM (Continuous Glucose Monitoring) data from a VEO insulin pump to CareLink…
- Trial name
- NCT01989975
- Where
- 2 sites in Denmark, Netherlands
- Volunteers
- 40 people
- Sponsor
- Medtronic MiniMed, Inc.
Quality of Life, Epilepsy (treatment Refractory)
Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data
The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology…
- Trial name
- SERAS_Home_RWD (NCT05845255)
- Testing
- mjn-SERAS
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 130 people
- Sponsor
- MJN Neuroserveis, S.L
Motor Seizures
Study of Algorithm for Epilepsy Alert Device
An accelerometer with transmitting ability is worn on the wrist. Data of movements during seizures will be analyzed to upgrade algorithm that will identify seizures.
- Trial name
- NCT00497835
- Volunteers
- 15 people
- Sponsor
- Biolert
Trauma Injury, Maxilla Fracture
Prospective Study to Evaluate the Performance and the Safety of Global D's Implants of Craniomaxillofacial Surgery (CMF) Ranges Indicated for Trauma Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK/MICROTEK®) used for…
- Conditions
- Trauma Injury, Maxilla Fracture, Maxillofacial Trauma
- Trial name
- NCT05742932
- Testing
- Trauma surgery using Global D's implants.
- Where
- 2 sites in France
- Volunteers
- 99 people
- Sponsor
- Global D
Periodontitis, Adult
Full Mouth Ultrasonic Debridement Carried Out Either by Piezoelectric or Magnetostrictive Device
Treatment of periodontitis requires removal of dental biofilm both through professional mechanical plaque removal and domiciliar oral hygiene procedures.
- Trial name
- NCT05279950
- Testing
- Full-mouth ultrasonic debridement with piezoelectric device (EMS, mini piezon), Full-mouth ultrasonic debridement with magnetostrictive device (Cavitron Select, Dentsply)
- Where
- Italy
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- University of Siena