Clinical trials: Medical Device Performance
Degenerative Diseases, Nervous System
Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure
- Trial name
- NCT03389048
- Testing
- PMD-200, SLR
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Medasense Biometrics Ltd
Diabetes
A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
The purpose of this study is to calibrate the performance of the KBS-1 non-invasive glucose monitoring device with diabetic people when compared to that of the standard method currently used in the clinical setting for…
- Trial name
- NCT03607435
- Testing
- Spectroscopy for Analyte Quantification
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Florida Hospital Tampa Bay Division
Colostomy Stoma
Multicenter Study to Describe the Performance of the AOS-C2001-B Device in Patients With Colostomy
The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
- Trial name
- NCT03108105
- Testing
- AOS-C2001-B
- Where
- France
- Volunteers
- 30 people
- Sponsor
- BBraun Medical SAS
Vascular Access Device Complications, Catheterization, Peripheral
Does a Novel Needle Over Catheter Device Improve First Pass Success and Decrease Complications
Emergency Department Patients who were to get intravenous (IV) access through routine medical care will receive it through trademarked catheter via convenience sample.
- Trial name
- NCT06547294
- Testing
- Osprey IV, Historical Controls
- Where
- United States
- Sponsor
- Community Medical Center, Toms River, NJ
Aortic Valve Stenosis
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
- Trial name
- NCT03699345
- Testing
- Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 11 sites in Denmark, France and 4 more
- Volunteers
- 87 people
- Sponsor
- Edwards Lifesciences
Amputees
Evaluation of a Multimodal Tactile Feedback System for Upper Limb-loss Users: Embodiment and Performance
The aim of this study is to evaluate the effect of integrating tactile feedback systems into a robotic upper-limb prosthesis. These systems deliver pressure stimuli (through small silicone chambers that inflate), vibration…
- Trial name
- THE_FBHAND (NCT07418645)
- Testing
- Pressure and vibrotactile feedbak, Pressure feedback, Vibrotactile feedback
- Where
- Italy
- Volunteers
- 9 people
- Sponsor
- University of Pisa
Sleep-Disordered Breathing
Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
- Trial name
- NCT05647746
- Testing
- Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
- Where
- Australia
- Volunteers
- 108 people
- Sponsor
- Compumedics Limited
Dry Nose
Osmonar® Nasal Gel Versus Saline Solution in Patients With Dry Nose
This study is being done to understand how well a medical device called OSMONAR Nasal Gel works and how safe it is for people who suffer from a dry nose.
- Trial name
- NCT07273318
- Testing
- Osmonar
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Michele Grasso
Performance and Safety of an Airway Management Device
Comparison of the BASKA Airway, a Novel Supraglottic Device, to the LMA Airway in Low Risk Female Patients
The investigators have performed a number of studies on novel airway devices, including an observational study on the performance of a new supraglottic airway named Baska mask.
- Trial name
- NCT01482650
- Testing
- supraglottic airway placement and use
- Where
- Ireland
- Volunteers
- 92 people
- Sponsor
- University College Hospital Galway
Proctological Disorders
A New Class IIb MD in Proctological Disorders
The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids…
- Trial name
- NCT03833076
- Testing
- Medical device Procto
- Where
- Italy
- Volunteers
- 118 people
- Sponsor
- Nathura S.p.A
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
Respiratory Failure, Respiratory Disease
Clinical Evaluation of EZVent in Hospitalized Mechanically Ventilated Patients
Investigation Device: EZVent Ventilator System is designed for respiratory support in hospitalized mechanical ventilated patients. The Ventilator is designed to be used for adults patients.
- Trial name
- NCT05399017
- Testing
- EZVent
- Where
- Egypt
- Volunteers
- 22 people
- Sponsor
- Triclinium Clinical Development Middle East and North Africa
Epilepsy, Brain Injuries
Hybrid Device DIALYTRODE for Multimodal Neuro-monitoring of Patients With Brain Injury and Status Epilepticus
This clinical trial evaluates the safety and diagnostic performance of a newly developed combined catheter that will be implanted into the brain of patients with severe brain injury for short time (up to 28 days) monitoring of…
- Trial name
- NCT03163485
- Testing
- Dialytrode, Standard treatment
- Where
- 2 sites in Germany
- Sponsor
- University of Erlangen-Nürnberg Medical School
Wrinkle
Open, Non-Comparative Study To Evaluate The Performance Of The Medical Device JANESSE®
The hypothesis of this clinical investigation is that in a population of men and women affected by periocular wrinkles, lip contour wrinkles or deep facial wrinkles, will cross-linked hyaluronic acid (Janesse) significantly…
- Trial name
- NCT04103125
- Testing
- Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.
- Where
- Romania
- Volunteers
- 61 people
- 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
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Large Hole Percutaneous Arterial Closure
Safety and Performance Study of Large Hole Vascular Closure Device - France
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 20 patients in 2 centres within France.
- Trial name
- FRONTIER V (NCT05323877)
- Testing
- Test Device (PerQseal+)
- Volunteers
- 20 people
- Sponsor
- Vivasure Medical Limited
Abnormalities, Jaw, Malocclusion, Angle Class III
First-In-Man Performance and Safety Evaluation of the CARLO® Device in Midface Osteotomies
The study product is a Cold Ablation Robot-guided Laser Osteotome (CARLO®) robotic surgery device. It is a device that removes hard tissue such as bone by means laser ablation - it is therefore an alternative to Piezo-Electric…
- Trial name
- NCT03901209
- Testing
- Mid-face osteotomy
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 31 people
- Sponsor
- Advanced Osteotomy Tools (AOT) AG
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.
Hypertension
OBPM_PANDA2026: Evaluation of the Performance and Safety of the Aktiia Periodic Optical Blood Pressure Monitoring Device
This study, with N = 85 participants minimum over 3 visits spread over 7 days, has been designed to assess the accuracy and precision of the Blood Pressure and pulse rate values as generated by Aktiia.product-G1-US for up to 7…
- Trial name
- OBPM_PANDA2026 (NCT07507903)
- Testing
- Device under test evaluation against references
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Aktiia SA