Clinical trials: Device Performance
Limb Length Discrepancy
Post-Market Study of the Ellipse PRECICE Intramedullary Limb Lengthening System
The purpose of this study is to obtain post market performance and safety data of the Ellipse PRECICE Intramedullary Limb Lengthening System for subjects undergoing unilateral limb lengthening.
- Trial name
- PINS (NCT01601301)
- Testing
- PRECICE System
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Ellipse Technologies, Inc.
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
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)
Healthy Volunteers, Adolescent
PureWick™ Adolescent Study
A prospective, uncontrolled, open-label healthy volunteer study to assess the performance of the PureWick Male and PureWick Flex Female external catheter devices in adolescents
- Trial name
- NCT06631313
- Testing
- PureWick System
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Hypertension
A Multi-centre Study Evaluating the Performance and Acceptance of the Hilo Band Cuffless Blood Pressure Medical Device in the Normo-, Hypo- and Hyper-tensive Young Population: a Comparison With the 24-h Ambulatory Blood Pressure Monitoring (ABPM)
Hypertension is one of the main risk factors for the onset of cardiovascular diseases. It is often silent, and most individuals are unaware they have it.
- Trial name
- IPSI-HYPE-001 (NCT07072689)
- Where
- 2 sites in Switzerland
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Simonetti Giacomo
Testing, Performance
Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections.
Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect hundreds of millions of people and are an important cause of global mortality and morbidity.
- Conditions
- Testing, Performance, Specificity, Sensitivity
- Trial name
- INSPiRED-WP3 (NCT04505046)
- Where
- Gabon
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Centre de Recherche Médicale de Lambaréné
Long-term and Permanent Contraceptive Methods
A Prospective Observational Study of the Clinical Performance of Zarin in Madagascar
This one-year observational study will monitor the contraceptive effectiveness, safety and acceptability of Zarin during the first year of use after the method has been approved for public use in Madagascar.
- Trial name
- NCT01200576
- Where
- Madagascar
- Volunteers
- 621 people, healthy volunteers welcome
- Sponsor
- FHI 360
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.
Malaria
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.
- Trial name
- NCT05286359
- Testing
- NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device
- Where
- Ethiopia
- Volunteers
- 1,023 people
- Sponsor
- Abbott Rapid Dx
Respiratory Diseases, Pneumonia
Performance and Safety of the Pneumoscope Device in Adults and Children
Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management.
- Conditions
- Respiratory Diseases, Pneumonia, Asthma, Cyanotic Heart Disease
- Trial name
- NCT06373939
- Testing
- Digital lung auscultation, Pulse oximetry measurement, Non invasive body temperature measurement
- Where
- Switzerland
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Pediatric Clinical Research Platform
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
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.
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
Fractures of the Long Bones, Vertically Stable Pelvic Fractures
Observational Study for the Evaluation of the Clinical Performance and Safety Profile of the GALAXY FIXATION™ System and Orthofix Implantable Devices: GALAXY Study
The GALAXY FIXATIONTM System and Orthofix implantable devices study intends to evaluate the clinical performance and safety profile of the study medical/investigational devices in the standard clinical practice.
- Conditions
- Fractures of the Long Bones, Vertically Stable Pelvic Fractures, Vertically Unstable Pelvic Fractures
- Trial name
- NCT06690437
- Testing
- Galaxy Fixation System and Orthofix implantable devices
- Where
- 3 sites in Italy
- Volunteers
- 3 people
- Sponsor
- Orthofix s.r.l.
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
Invasive Pulmonary Aspergillosis, Invasive Fungal Disease
LFD of Aspergillus Antigen in Paediatrics
Many children and young people are at risk of invasive fungal disease (IFD), such as those who have had a haematopoietic stem cell transplants, those with an immune deficiency or those who are prescribed immunosuppressive drugs…
- Trial name
- LFD-AsPaeds (NCT05569824)
- Testing
- Lateral-flow Device
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- St George's University Hospitals NHS Foundation Trust
Transfusion Reaction
Clinical Performance Study of the ABTest Card® Device.
The study aims to confirm the performance equivalence of the in vitro diagnostic device ABTest Card®REF with the ABTest Card®NEW device.
- Trial name
- NCT06557031
- Testing
- ABTest Card®REF and ABTest Card®NEW
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Diagast
Supraglottic Airway Devices, Laryseal Clear Laryngeal Mask
Clinical Performance of Laryseal Clear Versus Ambu Aura 40 Laryngeal Mask Airway for Preschool Children
Preschool children have specific anatomical and physiological characteristics which necessitates careful selection of an appropriate airway management device.
- Trial name
- NCT07553247
- Testing
- LarySeal clear Group, Ambu Aura40 Group
- Where
- Egypt
- Volunteers
- 54 people
- Sponsor
- Zagazig University
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
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