HomeCLINICAL TRIALS, STUDIES, REGISTRIES, DATA
CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Shanghai Operation Robot Announces the 1st Robot-assisted Human Clinical Trial of Biliary Stent Placement Surgery
Dr. Xiaofeng Zhang operated the robot outside the operating room (without wearing heavy lead), advanced the guidewire and balloon catheter in a precisely controlled manner and successfully completed the entire surgical procedure including the nipple cutter action, balloon stone removal, and accurate placement of bile duct stents.
Shockwave Confirms Consistent Outcomes for IVL in the Largest Prospective “Real World” Study of Patients with Heavily Calcified Peripheral Arterial Disease
The study represents the largest prospective “real world” evidence supporting the treatment of complex, heavily calcified peripheral arterial disease (PAD) with IVL. The final analysis was presented earlier today at VIVA22 in a late-breaking clinical trial session.
First Patient Enrolled in Reflow Medical’s DEEPER REVEAL IDE Clinical Study
The DEEPER REVEAL IDE Clinical Study is a prospective, single-arm, multicenter study that will examine the efficacy and safety of the Spur Stent for the treatment of vascular lesions in patients with critical limb ischemia
Envoy Medical Early Feasibility Study of Breakthrough Fully Implanted Cochlear Implant Now Underway
This surgery marks a key milestone for Envoy Medical on the road toward bringing the Acclaim Cochlear Implant to market. If approved by the FDA, the Acclaim would be the first-of-its-kind cochlear implant designed to be fully implanted and use the ear, rather than a microphone, to pick up sound.
TechsoMed Announces Completion of Full Enrollment in Pivotal U.S trial Evaluating its BioTraceIO Software for Liver Ablation Outcomes Assessment in Liver Cancer Patients
TechsoMed notes with its algorithm powered technology, the BioTraceIO software system is the first to provide visualization of the ablated area based on standard real-time ultrasound imaging intended to support interventional radiologists performing tumor ablation with valuable procedure outcomes assessment.
Theranica Achieves Positive Results in Placebo-Controlled Pivotal Trial of Nerivio® for Preventive Treatment of Migraine
This trial evaluated the efficacy and safety of Nerivio® for the preventive treatment of migraine in both episodic and chronic migraine patients. The study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients treated with Nerivio®, compared with a placebo device.
1st Patient Enrolled in Early Feasibility Study, Evaluating Doraya Catheter for Relieving Congestion in Acute Heart Failure (AHF) Patient
The Doraya catheter is placed in the Inferior Vena Cava below the renal veins, applying partial adjustable flow for up to 12 hours.
Hollister Secure Start ℠ Services has a Measurable Impact
Hollister announced the publication of a patient support program study through the Journal of Wound Ostomy & Continence Nursing (JWOCN). The study, titled A Cross-Sectional Survey Reporting on the Value of Patient-Centered Ostomy Programs: A Smooth Transition After Ostomy Surgery, focuses on connecting support service interactions to better results in areas of stoma barrier leakage, proper fit, and skin health1
Neuspera Medical Announces 1st Successful Implant of the Nuvella System in the 2nd Phase of It’s Sans-UUI IDE Clinical Trial
The study will evaluate the safety and efficacy of the Nuvella system, designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms.