Clinical trials: Medical Device Performance
Sepsis, Device Performance
PIVO Use for Blood Cultures in the Emergency Department
The investigators will implement a protocol for use of the PIVO device for blood culture collection in the emergency department.
- Conditions
- Sepsis, Device Performance, Emergency Medicine
- Trial name
- PIVO-ED (NCT07348289)
- Testing
- PIVO device, a needle-free blood draw device
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Intermountain Health Care, Inc.
Stoma Ileostomy
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
- Trial name
- NCT03929978
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
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
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.
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.
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
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.
Refractive Errors, Accomodation
Study in Pediatric Volunteers of a Handheld Device Versus a Standard Diagnostic Device in Ophthalmic Refraction
This study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.
- Conditions
- Refractive Errors, Accomodation, Diagnostic Self Evaluation
- Trial name
- NCT04955379
- Testing
- EQ103
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
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
Hypothermia
Clinical Performance of the Embrace Isothermal Mattress
The purpose of this pilot study is to evaluate the performance of a new warming technology (Embrace Isothermal Mattress) during the thermal weaning of premature infants from incubators to open cribs.
- Trial name
- KBW (NCT01425086)
- Testing
- Embrace, PCM, warming blanket
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Stanford University
Performance and Safety of an Airway Management Device
Comparison of the Baska Mask Airway to a Single-use LMA Device in Low-risk Female Patients
The purpose of this study is to compare the performance of the Baska mask supraglottic airway device with a single use laryngeal mask device (LMA) in low-risk female patients.
- Trial name
- NCT01753635
- Testing
- supraglottic airway placement and use
- Where
- Ireland
- Volunteers
- 150 people
- Sponsor
- John Laffey
COVID-19
Bioaerosol Sampling Device (BSD) Clinical Study
The goal of this clinical trial is to learn about the bioaerosol sampling device (BSD) and how it can sample patient bioaerosols (breath) and patient's nares for the detection of COVID-19 viral particles in patients seeking to be…
- Trial name
- NCT06047067
- Where
- 6 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Cantor BioConnect, Inc.
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
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
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
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
Sarcoma, Intracranial Neoplasm
Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's…
- Conditions
- Sarcoma, Intracranial Neoplasm, Pelvic Bone Neoplasm
- Trial name
- NCT06291662
- Testing
- 3D printer applications
- Where
- 3 sites in Italy
- Volunteers
- 12 people
- Sponsor
- Kathleen McGreevy
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
Bowel Dysfunction
An Evaluation of Navina Mini, a New Trans-anal Irrigation (TAI) Device in Children and Adolescents
The study is designed to deliver further information on clinical benefit, patients' satisfaction, and perception of handling and to confirm safety of Navina Mini when used in children and adolescents.
- Trial name
- NCT06385249
- Testing
- Navina Mini
- Where
- Sweden
- Volunteers
- 27 people
- Sponsor
- Wellspect HealthCare
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