Clinical trials: Medical Device Performance
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
Benign Brain Tumor, Malignant Brain Tumor
Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operative time and increasing…
- Trial name
- cCeLLExvivo (NCT06098248)
- Testing
- cCeLL - Ex vivo
- Where
- 4 sites in Canada, South Korea
- Volunteers
- 285 people
- Sponsor
- VPIX Medical
Diabetes Mellitus
Performance Characteristics and Safety Assessment of a Non-invasive Glucose Monitoring Device
This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.
- Trial name
- NCT03352518
- Testing
- WM3.4NR
- Where
- Denmark
- Volunteers
- 10 people
- Sponsor
- RSP Systems A/S
Implantable Cardioverter Defibrillators, CRT-D Cardiac Resynchronization Therapy Defibrillator
LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices
The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac…
- Trial name
- NCT02091011
- Where
- 80 sites in United States, Canada and 6 more
- Volunteers
- 1,600 people
- Sponsor
- Boston Scientific Corporation
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
Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis
PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty
This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System…
- Conditions
- Rheumatoid Arthritis With Adequate Bone Quality, Inflammatory Arthritis, Osteoarthritis, Hip, Avascular Necrosis
- Trial name
- NCT03372278
- Where
- 8 sites in Australia, Belgium and 6 more
- Volunteers
- 250 people
- Sponsor
- Zimmer Biomet
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
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
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
Vascular Access Complication
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and…
- Trial name
- NCT01937195
- Testing
- AccuCath Intravenous Catheter System
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- C. R. Bard
Diabetes Mellitus
Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device
This pivotal multicenter study has been launched to collect spectral Raman data paired with validated glucose reference values in diabetic patients.
- Trial name
- NCT04031300
- Testing
- Prototype 0.5
- Where
- 6 sites in Denmark, Germany and 2 more
- Sponsor
- RSP Systems A/S
Hepatolenticular Degeneration; Wilson
Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease
The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: Does the device work as expected by removing the excess of…
- Trial name
- MEXWILS (NCT05917327)
- Testing
- Low-volume continuous veno-venous haemodialysis
- Where
- 4 sites in France, Spain
- Volunteers
- 1 people
- Sponsor
- Mexbrain
Avascular Necrosis, Osteoarthritis
PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty
The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.
- Conditions
- Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Posttraumatic Arthritis
- Trial name
- NCT03672370
- Where
- 2 sites in Austria
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
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.
Endotracheal Intubation During Surgery, Hospital Acquired Infections
BIP ETT Clinical Tolerability, Safety and Performance Study
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s tolerability, safety and performance and compare it to a standard un-coated Endotracheal tube.
- Trial name
- BIPETT (NCT01682486)
- Testing
- BIP ETT (Bactiguard), Standard ETT
- Where
- Sweden
- Volunteers
- 30 people
- Sponsor
- Bactiguard AB
Overweight or Obesity
Multicenter Trial Investigating Performance and Safety of the Medical Device SiPore21®
The present clinical investigation is a randomized, double-blinded, placebo-controlled, multicenter international trial, planned to be conducted in Poland, Romania and Slovakia.
- Trial name
- SHINE (NCT06087822)
- Testing
- IMD SiPore21®
- Where
- 27 sites in Poland, Romania and 1 more
- Volunteers
- 318 people
- Sponsor
- Sigrid Therapeutics AB
Atrial Fibrillation, Afib
Clinical Performance of the AFGen1 Device Over a 7-day Period
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, Irregular Heart Beat, Arrhythmias, Cardiac
- Trial name
- NCT05295056
- Testing
- AFGen1 Device Wear Test, AFGen 1 Device Single Use
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- TriVirum, Inc.
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
Dry Eye, Contact Lens Acute Red Eye
Performance and Tolerability of the Medical Device LACRIACT
The goal of this study is testing LACRIACT® eye drops, a medical device, to see how well it works and if people can use it safely.
- Conditions
- Dry Eye, Contact Lens Acute Red Eye, Photophobia, Discomfort
- Trial name
- NCT06159569
- Testing
- LACRIACT
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- Laboratórios Baldacci S.A