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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA
Clinical trials, studies, data, and updates reported in Medical Device News Magazine.
Neuspera Medical Announces 2nd Phase of Sans-UUI IDE Clinical Trial with the Nuvella
The study will evaluate the safety and efficacy of Neuspera's Nuvella system designed to treat overactive bladder (OAB) for patients with urinary urgency incontinence (UUI) symptoms.
ProVIDE Clinical Study for BPH Treatment – 1st Patient Enrolled
The ProVIDE clinical study is a prospective, multi-center, double-blind controlled study to evaluate the safety, performance, and effectiveness of the ProVee System in patients with lower urinary tract symptoms secondary to BPH.
Enrollment Completed In ONWARD’s LIFT Home Study
LIFT Home Study is designed to study the safety and performance of ARCEX Therapy when used in the home.
Bone Health Technologies to Conduct 1 Year Long Study with the San Francisco Veterans Affairs Health Care System
Bone Health Technologies is looking to enroll 50 patients with diverse racial and ethnic backgrounds who are not currently taking any osteoporosis drugs and have DXA scan bone density T-scores between -1.0 and -2.4.
Aerin Medical’s RhinAer Demonstrates Long-term Safety and Efficacy for Treatment of Chronic Rhinitis in Newly Published 2 Year Study
Data from the trial demonstrated that treatment with RhinAer to the posterior nasal nerve (PNN) is safe and provides significant, durable symptom improvement for both chronic non-allergic and allergic rhinitis patients.
Clinical Data Presented at American Diabetes Association 82nd Scientific Sessions Reinforce Significant and Durable Benefits of Nevro’s HFX 10 kHz Therapy
The data presented at the ADA 82nd Scientific Sessions highlighted 24-month results for the original 10 kHz arm of the SENZA-PDN trial, the largest PDN RCT of SCS treatment conducted to date with 216 randomized subjects at 18 U.S. centers.
Control-IQ Technology Continues to Demonstrate Positive and Sustained Real-World Benefits Across Diverse Cohorts of People with Diabetes
“Our Control-IQ technology continues to be a great equalizer for people with insulin-intensive diabetes, as we consistently see positive clinical and quality-of-life improvement with its use, regardless of age, ethnicity, or prior therapy,” said Jordan Pinsker, MD, Vice President and Medical Director for Tandem Diabetes Care.
Orbis Reports First-of-its-Kind Study Finds Artificial Intelligence Screenings Improve Eye Care Access in Sub-Saharan Africa
The study looked at whether the use of the Orbis Cybersight AI tool to detect diabetic retinopathy in images taken of the eye during routine screenings would lead to patients' increased uptake of diabetic retinopathy referral services.
Neuros Medical Announces Completion of QUEST Pivotal Trial 90-day Primary Endpoints
QUEST Pivotal Trial is a 180-subject randomized, double-blinded, active sham-controlled clinical trial that is being conducted under an Investigational Device Exemption