HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
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 .
Sound Stimulation in Hearing Aids Shows Positive Effects for Tinnitus Treatment and Overall Well-Being
“Widex SoundRelax is the latest evolution in our evidence-based approach to tinnitus treatment, which leverages patented fractal tones algorithmically generated within Widex hearing aids. First introduced for tinnitus patients through Widex Zen tones, we’ve expanded the tone choices and included new modulated wave-like sounds, offering more options to help all wearers, with or without tinnitus, combat stress and sustain health,” said Dana Helmink, Senior Director of Audiology and Clinical Education at Widex USA.
Cook Medical Treats First Patient in First-in-human Clinical Trial for Venous Valve
The patient was treated by Dr. Mauricio Alviar, vascular surgeon and principal investigator, of Clinica de la Costa in Barranquilla, Colombia.
Research Study on Comfort of the New FLUME Catheter to Begin Recruitment
The FLUME catheter, which received clearance in November 2021 from the U.S. Food and Drug Administration (FDA), is designed to address some of the triggers that can negatively impact patients’ comfort and quality of life.