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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Clinical trials, studies, data, and updates reported in Medical Device News Magazine.

AppliedVR and Kernel Flow Announce Clinical Results Evaluating How Brain Changes During Virtual Reality Treatment of Chronic Pain

AppliedVR Co-founder and President Josh Sackman, “We’re committed to developing a significant body of scientific evidence that demonstrates how our RelieVRx program, which is rooted in self-regulation, cognitive behavioral therapy skills and mindfulness, engages the brain and can impact the experience of pain. While we know there can be a strong placebo effect, this feasibility study showed that only the active RelieVRx treatment created changes at a physiological and brain activity level, creating a strong foundation for future research.”

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Invizius Treats First Patients in First-In-Human Phase 1 Clinical Study of Lead Dialysis Product H-Guard ®

First patients treated with H-Guard at the National Institute for Health and Care Research Manchester Clinical Research Facility. MHRA approves continuation of Invizius’s first-in-human clinical study following a prearranged two-patient safety and performance review. Study is investigating safety and tolerability of H-Guard®, a second generation complement regulator, to address serious immune system-driven complications of dialysis.

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Dilon Technologies Announces the Beginning of Enrollment in its Pivotal Trial of the Next Generation MarginProbe™ 2 Used in Real-Time Margin Assessment

Dilon Technologies looks to continue building evidence around its MarginProbe™ platform that already has over 12 peer-reviewed publications demonstrating reduction in re-excision rates. “We remain committed to being a leader in women’s healthcare by providing technology for patients that will improve their outcomes. MarginProbe™ is beginning to become an integral component of breast surgery for more surgeons across the United States each month,” stated George Makhoul, CEO of Dilon Technologies.

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Boston Scientific Initiates Randomized Controlled Trial for the EkoSonic™ Endovascular System EKOS

Randomized Controlled Trial for the EkoSonic™ Endovascular System Commences

“Optimal treatment of PE is still poorly understood and there is a need for a coordinated institutional approach to this complex, life-threatening problem,” said Kenneth Rosenfield, M.D., study co-lead principal investigator and section head, Vascular Medicine and Intervention, Division of Cardiology, Massachusetts General Hospital, Boston. “The lead investigators of the trial are pleased to collaborate with the PERT Consortium, which is committed to evidence-driven therapy and is proud to take part in the HI-PEITHO study, aiming to advance the care of patients with PE.”

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