Ultrasound-Guided nsPFA for Primary Hyperparathyroidism
(VYBRANCE-PHPT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to treat patients with the nPulse system and evaluate their outcomes following treatment. The study seeks to characterize patient outcomes and assess changes in serum calcium, ionized calcium, and parathyroid hormone (PTH) levels after treatment with nPulse.
Who Is on the Research Team?
Ralph Tufano, MD
Principal Investigator
Sarasota Memorial Hospital
Are You a Good Fit for This Trial?
This trial is for people diagnosed with primary hyperparathyroidism (PHPT), a condition where the parathyroid glands make too much hormone. Specific inclusion and exclusion criteria are not listed, but participants must have PHPT.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA)
Trial Overview
The study is testing an ultrasound-guided procedure called nanosecond pulsed field ablation (nsPFA) using the nPulse Vybrance PE System to treat overactive parathyroid glands. Researchers will monitor changes in calcium and hormone levels after treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adults aged 21 years or older with a confirmed diagnosis of primary hyperparathyroidism (PHPT) who meet established criteria for parathyroidectomy as defined by the current American Association of Endocrine Surgeons (AAES) guidelines.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pulse Biosciences, Inc.
Lead Sponsor
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