Clinical trials: Device Performance
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
Asthma, COPD
An Open Study to Assess the Robustness of the CRC749 Inhaler
To confirm the robustness of the CRC749 inhaler.
- Trial name
- NCT02474017
- Testing
- MGR001, CRC749 inhaler
- Where
- 2 sites in United Kingdom
- Volunteers
- 111 people
- Sponsor
- Mylan Pharma UK Ltd.
Airway Morbidity
Bronchoscopic Endotracheal Intubation Through a SAD - Physician Performance
Prospective observational study with the primary objective is to assess technical competence in anaesthesiology specialists who perform bronchoscopic endotracheal intubation through a supraglottic airway device (SAD), by using a…
- Trial name
- NCT04743440
- Testing
- Bronchoscopic endotracheal intubation through a supraglottic airway device
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Nordsjaellands Hospital
Cochlear Implants
Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Information for Compatible MED-EL Audio Processors, by Analyzing Data Logged by the App and Responses to a User Survey
Investigating the performance and safety of the AudioKey 3, a device that provides remote control options and status information for compatible MED-EL audio processors, by analyzing data logged by the app and responses to a user…
- Trial name
- NCT06817928
- Where
- Austria
- Volunteers
- 46 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Focus of Study: Accurate Clinical Measurement and Diagnosis
TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters
This study aims to provide evidence on next-generation clinical measurement tools through a mixed methods diagnostic accuracy and implementation study in Kenya, Senegal, Tanzania, and Uttar Pradesh, India.
- Trial name
- NCT05527990
- Testing
- Multimodal PO
- Where
- 2 sites in Kenya
- Volunteers
- 650 people
- Sponsor
- PATH
Rheumatoid Arthritis (RA)
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
- Trial name
- NCT01871961
- Testing
- Methotrexate (Metoject® prefilled pen)
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- medac GmbH
Respiratory Rate Monitoring
Respiration From Pleth Validation
This observational clinical investigation evaluates the performance of respiratory rate derived from the plethysmography waveform (Respiration from Pleth, RfP) using Philips FAST Pulse Oximetry technology.
- Trial name
- RfP Validation (NCT07449715)
- Testing
- Physiological Monitoring with SpO₂ Sensors and Capnography
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 113 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Colo-rectal Cancer
Therascreen® KRAS RGQ PCR Kit
An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from patients with Colorectal Cancer (CRC) who have previously tested positive for the KRAS G12C mutation for…
- Trial name
- NCT05347745
- Testing
- therascreen® KRAS RGQ PCR Kit
- Where
- United Kingdom
- Volunteers
- 219 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Sudden Cardiac Arrest, Emergency Care
Tempus Pro Monitor Registry
A multicenter, prospective and retrospective, observational, post market study.
- Trial name
- NCT05587764
- Testing
- Standard of Care
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Heartstream US LLC
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
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
Functionality and Performance of Device
Pediatric Optimization of the PharmaJet Needle-Free Intradermal Delivery System
The PharmaJet needle-free injection system is a consistent approach to delivering injectates into the dermal layer of the human skin for the purpose of vaccination or medication delivery.
- Trial name
- PharmaJet (NCT01494571)
- Where
- United States
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Burns
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review.
- Trial name
- NCT03333941
- Testing
- ReCell® Autologous Cell Harvesting Device
- Where
- 6 sites in United States
- Volunteers
- 76 people
- Sponsor
- Avita Medical
General Anesthesia, Supraglottic Airway Device
The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy
The supraglottic airway device (SAD) is currently widely used in patients undergoing general anaesthesia as a method of securing the airway.
- Conditions
- General Anesthesia, Supraglottic Airway Device, Laryngeal Mask Airway
- Trial name
- NCT03643029
- Testing
- Video-laryngoscopy following SAD insertion
- Volunteers
- 50 people
- Sponsor
- University of Malaya
Prematurity
Effect of Monitoring Devices on Healthcare Provider Performance During Neonatal Resuscitation
Babies born very early (at less than 32 weeks) usually need help to breath right at birth, also called neonatal resuscitation. Healthcare providers (HCPs) are specially trained to provide this help.
- Trial name
- NCT04521725
- Testing
- Respiratory Function Monitor (RFM), Cerebral Near-Infrared Spectroscopy (NIRS)
- Where
- Canada
- Volunteers
- 51 people
- Sponsor
- University of Alberta
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management.
- Trial name
- CR-01-001 (NCT00889668)
- Testing
- GlucoTrack
- Where
- Israel
- Volunteers
- 180 people
- Sponsor
- Integrity Applications Ltd.
Malaria, RDT
Abbott NxTekTM Malaria RDT WHO Prequalification Study
Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria but proved insufficient to support elimination efforts because of their limited sensitivity…
- Conditions
- Malaria, RDT, Diagnoses Disease
- Trial name
- NCT05444790
- Testing
- Rapid Diagnostic Test
- Where
- 3 sites in Indonesia, Peru and 1 more
- Volunteers
- 4,563 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Airway Management
Head Position for Laryngeal Mask Air Leak and Performance in Paediatric Patients (Neutral, Sniffing and Beyond Sniffing Position)
The correct head position for airway management is considered as a mainstay of good clinical practice. The recommended head position for all patients is the horizontal position of the head with in tragus-to- sternal notch in line…
- Trial name
- SNIFFLMA (NCT05035264)
- Testing
- Laryngeal mask insertion
- Where
- Czechia
- Volunteers
- 205 people
- Sponsor
- Brno University Hospital
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