Clinical trials: Medical Device Performance
Healthy Subjects
A Three-phase Study That Will Compare the ECG Data Recorded Using the Test Device With the Data Recorded by a Reference Device, Evaluate the ECG Signal Quality of the Test Device Over a 10-day Simulated Use Period, and Assess the Effects of Variable ECG Electrode Placement for the Test Device
This clinical study will be performed in three phases. The purpose of Phase 1 of this study is to compare the ECG data recorded using the ZywieZ3 Sensor and ZywieZ3 Adhesive ("Test Device") to the data recorded by a traditional…
- Trial name
- NCT07200232
- Testing
- Phase 1 Test Device Sensor and Adhesive and Reference Device, Phase 2 Test Device ECG Signal quality over a 10-day simulated use period, Test Device Sensor and Adhesive Variable Placement
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Zywie, Inc.
Facial Wrinkles, Skin Aging
Evaluation of MD60002 Device for Facial Skin Aging
This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic…
- Conditions
- Facial Wrinkles, Skin Aging, Skin Imperfections
- Trial name
- CIP-02-25 (NCT07881926)
- Testing
- Device: MD60002
- Where
- Italy
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Promoitalia Group Spa
Scar
Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to improve wound healing and the…
- Trial name
- PMCS EURO HEAL (NCT01706848)
- Testing
- Celotres, Surgical Closure by Standard of Care
- Where
- 9 sites in Poland, United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Halscion, Inc.
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
Coronavirus, COVID
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-2 Device
The current available diagnostic methods used for the detection of COVID-19 takes up to 4 hours. In some cases, these diagnostics tests make take up to a couple of days.
- Trial name
- NCT04357977
- Testing
- RBA-2
- Where
- 3 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Kaligia Biosciences, LLC
Atrial Fibrillation, Afib
Clinical Performance of AFGen1
AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib.
- Conditions
- Atrial Fibrillation, Afib, ECG
- Trial name
- NCT06076798
- Testing
- ECG co-measurement
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- TriVirum, Inc.
Wrinkle
Study to Evaluate the Performance and Safety of the Medical Device Plenhyage®
The Research Question of the present study is the following: in a population of men and women affected by face wrinkles and skin tones and irregularities (atrophies) of the skin surface in neck, abdomen, thighs and buttocks, will…
- Trial name
- Plenhyage (NCT04650620)
- Testing
- Plenhyage® thin, Plenhyage® medium, Plenhyage® strong
- Where
- Romania
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
Overweight, Obesity
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
Study design to demonstrate the safety and performance of the Epitomee Device
- Trial name
- NCT03610958
- Testing
- Epitomee Device
- Where
- Israel
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Epitomee medical
No Condition, Healthy Individuals
Microneedle-based ISF Sampling Technique
This clinical investigation aims to evaluate the performance and safety of the PELSA system, a hollow microneedle-based medical device designed for the collection of dermal interstitial fluid (dISF) from human skin.
- Trial name
- MIST (NCT07882225)
- Testing
- PELSA System
- Where
- Germany
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Ascilion AB
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
Contraception
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services
Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.
- Trial name
- NCT02718222
- Testing
- Post-partum IUD
- Where
- 3 sites in Nepal, Sri Lanka and 1 more
- Volunteers
- 140,258 people, healthy volunteers welcome
- Sponsor
- Harvard School of Public Health (HSPH)
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
Pulse Oximetry
PULSE OXIMETRY Performance Test for a Software Medical Device 'Vitacam'
This clinical investigation aims to collect data for algorithm development and testing of Vitacam as well as to later validate the system using a simultaneously collected, but segregated, hold-out validation dataset.
- Trial name
- NCT06912516
- Testing
- Controlled desaturation
- Where
- Finland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Evondos Oy
Concussion, Mild, Autonomic Nervous System
Acute Nerve Stimulation For Enhancing Human and Cognitive Performance
The goal of this clinical trial is to test a wearable device's effect on performance in tactical populations with a history of concussion.
- Conditions
- Concussion, Mild, Autonomic Nervous System, Cognitive
- Trial name
- NCT05675956
- Testing
- Experimental group with 100% intensity setting on Apollo Neuro device, Active Comparator group with 10% intensity setting on the Apollo Neuro device
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- University of South Carolina
Neurological Disorders, Health Adult Subjects
Device for Driving Simulation for the Rehabilitation of Balance and Proprioception
The DriveSim clinical trial investigates a dynamic driving simulator designed to train and assess functional motor and cognitive skills in individuals with neurological disorders.
- Trial name
- DRIVESIM (NCT07539272)
- Testing
- DriveSim Rehab, Conventional Rehabilitation
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Pavia
Skin Aging
Evaluation of the Performance and Safety of the MD60000 Device in the Treatment of Skin Imperfections Due to Aging.
Here is the English translation of the summary: The Clinical Investigation Plan with code CIP-01-25 outlines a single-center, uncontrolled, single-arm clinical study sponsored by Promoitalia Group S.p.A.
- Trial name
- MD-AGE (NCT07873112)
- Testing
- MD60000
- Where
- Italy
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Promoitalia Group Spa
Port a Cath
Structured Training on Oncology Nurses' Performance Related Port A Cath Device
evaluate the effect of structured simulation-based training on oncology nurses' performance regarding port A cath device.
- Trial name
- NCT05774301
- Testing
- simulation-based training
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mansoura University
Medical Device, Medical Device Performance
Clinical Evaluation of an Airborne Pathogen Containment Device: Randomized Open-label Equivalence Trial During Endotracheal Intubation
The aim of this study is to test a bubble-like dome (made of clear plastic) being placed over patients' heads during surgery as a tool to prevent the spread of germs through the air in hospitals.
- Conditions
- Medical Device, Medical Device Performance, Aerosol Generating Procedure
- Trial name
- NCT06968377
- Testing
- A novel airborne pathogen containment device.
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre
Non-Verbal Communication, Degenerative Neurologic Disease
Brain-computer Interface Commercial Readiness
The goal of this clinical trial is to evaluate the commercial readiness of an Augmentative and Alternative Communication Brain-Computer Interface (AAC-BCI) device for people with minimal movement who benefit from expressive…
- Trial name
- NCT06521736
- Testing
- AAC-BCI device
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Kendrea Garand
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