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
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
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
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
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
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
Vascular Access Device
A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices
The objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality data on the performance, safety, and clinical benefits of Teleflex's vascular access devices when used in a real-world setting
- Trial name
- VADER (NCT06604039)
- Testing
- Central venous catheter
- Where
- 3 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Teleflex
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
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
Stoma Ileostomy
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device.
- Trial name
- NCT03784989
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
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
Tooth Disease
Performance and Tolerability of a New Medical Device Gel, a Randomized, Open Label, Parallel-group, Multicentre Study
Medical device study for efficacy and tolerability of a HA gel in the management of teething symptoms
- Trial name
- NCT03423784
- Testing
- HA BPX V3.3, Dentinox-Gel N
- Volunteers
- 54 people
- Sponsor
- Opera CRO, a TIGERMED Group Company
RDS of Prematurity, Preterm Birth
Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Clinical pilot study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT06917326
- Testing
- Monitoring
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Neola Medical AB
RDS of Prematurity, Preterm Birth
Pivotal Study to Assess Safety and Performance of Neola®, a Novel Lung Monitoring Device for Neonates
Pivotal study to assess safety and performance of Neola®, a novel lung monitoring device for neonates
- Conditions
- RDS of Prematurity, Preterm Birth, Lung Diseases
- Trial name
- NCT07060911
- Testing
- Lung monitoring with the Neola device
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Neola Medical Inc
Diabetes Mellitus, Type 1
Pediatrics Owning Performance Study
A more convenient blood glucose monitoring system integrated with a responsive mobile health app may facilitate improved diabetes control in adolescent and young adult patients with Type 1 diabetes.
- Trial name
- POPS! (NCT03251846)
- Testing
- Pops! One personalized mobile platform
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Children's Hospitals and Clinics of Minnesota
Performance and Safety of an Airway Management Device
A Comparison of the Performance of Standard Double Lumen Tubes With Vivasight DL™ Double Lumen Tubes for Lung Isolation in Patients Undergoing Thoracic Surgery
The investigators have performed a number of studies on novel airway devices. In this randomized controlled trial he investigators would like to compare the performance of a new double-lumen endotracheal tube incorporating…
- Trial name
- NCT01757977
- Testing
- double lumen endotracheal tube placement and use
- Where
- Ireland
- Volunteers
- 25 people
- Sponsor
- John Laffey
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
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)
Scoliosis
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
It is current practice for children who have surgery for early onset scoliosis (EOS) to be treated with insertion of extendable implants known as growth rod systems.
- Trial name
- NCT01362881
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Ellipse Technologies, Inc.