Clinical trials: Device Performance, open to volunteers
Temperature Change, Body, Emergency Department Visit
Performance Study of the Thermodiag Solution for Body Temperature Measurement
The goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the Thermodiag® medical device, compared with reference methods, for continuous measurement of core…
- Trial name
- ThermodiagPERF (NCT06703931)
- Testing
- Measures performed on all subjects
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- F2D Medical
Hemostasis, Distal Radial Artery Access (dTRA)
Evaluation of Safety, Performance and Usability of the TR Band DISTAL Device for Hemostasis Following Distal Radial Access in Coronary Procedures
This clinical study has been organised to learn more about the safety and use of the TR Band Distal device in patients who have had a heart procedure through a blood vessel in the wrist near the base of the thumb (called distal…
- Trial name
- EASY DISTAL (NCT07888738)
- Testing
- TR Band Distal
- Where
- 7 sites in Austria, Belgium and 2 more
- Volunteers
- 320 people
- Sponsor
- Terumo Europe N.V.
Lower Limb Amputation
Exploratory Functional Assessment After Lower Limb Amputation: Locomotion, Balance, Energy Performance and Strategies for Adapting to Orthopaedic Devices
The general aim of this exploratory study is therefore to investigate and quantify the functional capacities of patients with lower limb amputations (transtibial and transfemoral), with no change in their management, and to…
- Trial name
- AMILOCO (NCT07094074)
- Testing
- Walk tests, Functional testing, Balance analysis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Sepsis
Performance and Impact of the Sepsis ImmunoScore
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
- Trial name
- NCT07543497
- Testing
- Sepsis ImmunoScore
- Volunteers
- 5,000 people
- Sponsor
- Prenosis, Inc.
Arthroplasty, Hip, Replacement
Study to Evaluate the Performance and Safety of ATF Implants and Lapé Médical Devices Implanted During Hip Arthroplasty
Observational and prospective multicenter study to evaluate the long-term (10 years) performance and safety (10 years) of ATF Implants and Lapé Médical devices implanted during total hip arthroplasty or hemiarthroplasty.
- Trial name
- NCT05044767
- Testing
- total hip arthroplasty
- Where
- 13 sites in France
- Volunteers
- 4,500 people
- Sponsor
- ATF Implants
Visual Acuity
Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements
The purpose of this research is to validate and determine the accuracy of the experimental device when measuring visual acuity versus our standard visual acuity measurements and to gather voice recordings of letters to help build…
- Trial name
- NCT06431295
- Testing
- FaceScan
- Where
- United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Trapeziometacarpal Osteoarthritis, Rhizarthrosis
Evaluation of the Performance and Safety of a Type I Collagen-Based Medical Device (MD-Small Joints Collagen Medical Device) i the Treatment of RHIZOARTROSIS
Collagen is a structural protein biopolymer consisting of three polypeptide chains wrapped around to form a right-handed triple helix.
- Conditions
- Trapeziometacarpal Osteoarthritis, Rhizarthrosis, MEDICAL DEVICE, Infiltrate
- Trial name
- SMAGENART (NCT06781554)
- Testing
- MD-Small Joints Collagen Medical Device
- Where
- Italy
- Volunteers
- 42 people
- Sponsor
- Guna S.p.a
PHYSIOLOGICAL PHENOMENA, Homeostasis
Truway Whole-Body Digital Twin and Physiologic Resilience Study (TRU-OMNIBODY)
TRU-OMNIBODY is a prospective observational study designed to develop and independently validate a research-only whole-body digital twin.
- Conditions
- PHYSIOLOGICAL PHENOMENA, Homeostasis, Physical Functional Performance, Cardiorespiratory Fitness
- Trial name
- TRU-OMNIBODY (NCT07805044)
- Testing
- Standardized Physiologic Resilience Challenge, Multimodal Whole-Body Physiologic Monitoring, Research-Only Whole-Body Digital Twin Analysis
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
Pancreas Cancer, Pancreatic Ductal Adenocarcinoma
Clinical Performance of Medical Device Software "Lipidica 1.0" for Processing Data Generated by Lipidomic Analysis in Pancreatic Cancer Screening
Software "Lipidica" is intended to be used for processing data generated by the in-house in vitro diagnostic medical device for lipidomic testing for the purpose of screening Pancreatic cancer (PaC) in the population at high risk…
- Conditions
- Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Hereditary Diseases, Pancreatitis, Chronic
- Trial name
- NCT06549725
- Testing
- software Lipidica, endoscopic ultrasonography, magnetic resonance
- Where
- 16 sites in Czechia
- Volunteers
- 419 people, healthy volunteers welcome
- Sponsor
- Lipidica, a.s.
Obstructive Sleep Apnoea (OSA)
A Study Assessing Adult Patients Referred to an NHS Sleep Service With Suspected Obstructive Sleep Apnoea. This Study Aims to Compare the Sunrise Wearable Diagnostic Device Performance and Potential Inclusion in a NHS Diagnostic Pathway With Oximetry and WatchPAT Which Are Currently Used.
The goal of this clinical trial is to evaluate whether the Sunrise device (that measure small jaw movements) can improve the diagnosis and management of Obstructive Sleep Apnoea (OSA) in adults (≥ 18 years) referred to a Sleep…
- Trial name
- SOSA (NCT07269483)
- Testing
- WatchPAT 300, Oximetry, Sunrise
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Virginia Hawkins
Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2
The BRIGHT Study (Device Name: HALO System)
The purpose of the BRIGHT study is to evaluate safety and performance of the HALO SYSTEM in subjects with diabetes mellitus. The primary objectives of this clinical investigation are 1) the evaluation of sensor's performance by…
- Conditions
- Diabetes Mellitus - Type 1, Diabetes Mellitus - Type 2, Diabetes Mellitus, Ketoacidosis, Diabetic
- Trial name
- NCT07745998
- Testing
- The HALO System
- Volunteers
- 12 people
- Sponsor
- Indigo Diabetes NV
Post Operative Pain, Chronic Pain
Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery
Acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year. Effective analgesic therapy in the first postoperative week is a key factor in reducing early…
- Trial name
- TRACE (NCT07680998)
- Testing
- Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Blood Pressure Monitoring, Ambulatory
Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)
The Corsano CardioWatch 287-2 is a medical wearable device that can monitor blood pressure. The device has been validated using clinical trials in hospitals.
- Trial name
- COR-BP (NCT07633886)
- Testing
- Non-invasive blood pressure measurements with the Corsano CardioWatch 287-2, Auscultatory blood pressure measurement
- Volunteers
- 170 people
- Sponsor
- Corsano Health B.V.
Artery Disease
Investigating the Safety and Clinical Performance of Eight iVascular Devices for Endovascular Intervention in Renal, Iliac or Femoral Arteries
The rationale of this study is to confirm and support the clinical safety and performance of any of these products in a real-world population of 209 patients who underwent an endovascular intervention within standard-of-care of…
- Trial name
- NCT05902923
- Testing
- endovascular intervention
- Where
- 6 sites in France
- Volunteers
- 209 people
- Sponsor
- iVascular S.L.U.
Bacterial Vaginosis (BV), Recurrent Bacterial Vaginosis
Evaluation of the Medical Device Vagitab - T as Adjuvant Therapy in Patients With Bacterial Vaginosis.
This clinical trial is looking at how well and safely the vaginal administration of Vagitab-T works . Vagitab-T is already on the market in several countries in Europe as a medical device.
- Trial name
- Vagitab (NCT06725888)
- Testing
- Vagitab -T vaginal tablets. Components: tyndallized probiotic L. plantarum HA-119, lactic acid, and xylo-oligosaccharides, lauryl glucoside, and macrogol 3350:
- Where
- Romania
- Volunteers
- 30 people
- Sponsor
- S.I.I.T. Srl
Heart Diseases
ACCESS Registry: A Post Market Follow-up Study to Monitor the Safety, Performance and Usability of Occlutech Accessory Medical Devices
The registry is an international, multicenter, non-randomized, non-invasive study to assess the safety, performance and usability of the Occlutech Accessories "Occlutech Delivery Set (ODS), Occlutech Pistol Pusher (OPP)…
- Trial name
- NCT05174442
- Where
- 36 sites in Germany, Turkey (Türkiye)
- Volunteers
- 685 people
- Sponsor
- Occlutech International AB
Cerumen Impaction, Earwax Impaction
Performance, Safety and Participant Satisfaction Regarding A-CERUMEN® Medical Devices Used for the Removal of Earwax.
The ear canal - or external auditory meatus - is lined with skin that contains ceruminous glands. Cerumen - or earwax - is a combination of epithelial cells, dust, foreign bodies, as well as the secretions of the sebaceous glands…
- Conditions
- Cerumen Impaction, Earwax Impaction, Earwax Plug
- Trial name
- EAR (NCT07834593)
- Testing
- Unidose cerumenolytic solution, Spray cerumenolytic solution
- Where
- 3 sites in France
- Volunteers
- 80 people
- Sponsor
- Laboratoires Gilbert
Breast Neoplasm
A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients at High Risk for Breast Cancer
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a…
- Trial name
- NCT06672302
- Testing
- ExoPred
- Where
- 3 sites in United States, South Korea
- Volunteers
- 330 people
- Sponsor
- EXoPERT
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
Dry Eye Disease (DED), Cataract Surgery
POST CATARACT SURGERY DRY EYE DISEASE
Cataract surgery is one of the most frequent and successful interventions currently undertaken in medicine. However, a significant number of patients who underwent cataract surgery still complain about postoperative symptoms…
- Trial name
- NCT07715266
- Testing
- NOX-01
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- NOXELIS