HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea
The nausea study revealed how nausea can affect daily life in many unpleasant ways. More than 18% of respondents reported that their nausea actively hindered their ability to travel, while some could not socialize (3.2%) or even work (2.9%). These findings highlight how nausea extends beyond mere inconvenience for a large majority of the U.S. population.
Akura Medical Announces Successful First-in-Human Use of its High Performance Mechanical Thrombectomy Platform
While the use of mechanical thrombectomy devices has been increasing, current options are procedurally complex, use large bore devices, are frequently inefficient, and have difficulty reaching the target anatomy.
Aditxt Subsidiary Adimune Signs Clinical Trial Agreement with Top Research Institution to Study Stiff Person Syndrome
Adimune™ has signed a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person Syndrome. Adimune was founded earlier this year to lead Aditxt’s immune modulation therapeutic programs.
DermaSensor’s Non-Invasive Skin Cancer Device Found to Halve the Number of Skin Cancers Not Referred by PCPs
Of the two studies presented, one demonstrated the standalone performance of the hand-held, non-invasive device, and the other evaluated the impact of the device on PCPs’ management of skin cancer.
Stanford Spinoff PhysioWave Announces Clinical Study with Omron Healthcare
The PhysioWave Pro™ scale measures the stiffness of the major blood vessel into which the heart pumps, the aorta. Stiffness increases with age, but excess stiffness among people of similar ages can be a warning sign of risk. It is established that increased vascular stiffness can predict the later development of high blood pressure, or hypertension, and a higher risk of cardiovascular disease.
MedAlliance Enrolls First US Patient into its Third FDA IDE Study: SFA SELUTION4SFA
SFA SELUTION4SFA is being conducted in over 30 centers in the US plus an additional 10 centers worldwide. The study will enroll 300 patients, with the aim of demonstrating the superiority of SELUTION SLR over balloon angioplasty (POBA). The primary efficacy endpoint is primary patency of the target lesion at 12 months and the primary safety endpoint is freedom from death at 30 days. Enrollment into the study will be complete by the end of 2023.
Economic Study Shows Significant Cost Savings when Using Venock Device for Large Bore Venous Access Site Closure
According to a new study, this device could provide cost savings of more than $1,700 per procedure. In addition, the device will enable same-day patient discharge providing a cost savings of up to $6,290 per patient. The Venock device replaces the tedious and lengthy manual compression steps currently used to close venous access sites after a catheterization - a decades old procedure that is extremely burdensome to patients. Medical approval of the device is forthcoming.
BEAR Implant Registry Study Launched, to Track Outcomes Up to Two Years/30 U.S. Sites
The BEAR Implant serves as a bridge to restore the patient’s own ACL and is the first medical technology that has been clinically proven to enable healing of a torn ACL. It is a paradigm shift from the current standard of care – reconstruction that replaces the ACL with a graft.
Vivasure Medical Announces Enrollment of First Patients in Pivotal PATCH Study
The first patients were enrolled at Kaleida Health's Buffalo General Medical Center-Gates Vascular Institute in Buffalo, New York by Dr. Vijay Iyer, Chief of Cardiology at the University of Buffalo and Director, Structural Heart Interventions at Buffalo General Hospital advises Vivasure Medical .