Pulse Biosciences, Inc.
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.
This prospective, non-randomized, single-center study is evaluating nPulse for the treatment of primary hyperparathyroidism (PHPT). All participants will receive a single nPulse™ treatment of the targeted parathyroid gland and will be followed through 12 months post-procedure with biochemical assessments and high-resolution neck ultrasound. Participants will be evaluated for parathyroid surgery at the 3-, 6-, and 12-month follow-up visits.
Inclusion Criteria: * Participants at least 21 years of age. * Participant has classical hyperparathyroidism defined by elevated albumin-corrected serum calcium, serum ionized calcium and intact parathyroid hormone level * Participant qualifies for surgery to treat PHPT according to AAES guidelines as follows: Symptomatic PHPT patients diagnosed with primary hyperparathyroidism (clinical symptoms and/or biochemical disturbances), such as those with symptoms in any system including the kidneys, bones, gastrointestinal tract, psychoneurological system, or those with atypical symptoms such as mu…
Participants will undergo ultrasound-guided, non-surgical, non-thermal nanosecond pulse field ablation (nsPFA) of the targeted parathyroid gland using the nPulse™ system.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.