An interventional study of Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA) in Primary Hyperparathyroidism, sponsored by Pulse Biosciences, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Pulse Biosciences, Inc. · Not applicable, Interventional, and Treatment
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.
104 studies on the registry are indexed under Hyperparathyroidism, Primary; 23 are open to participants now.
This study's planned enrollment of 15 is below the median of 68 across 60 interventional studies indexed under Hyperparathyroidism, Primary.
Browse Hyperparathyroidism, Primary studies →Pulse Biosciences, Inc. is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 muscle weakness, dysfunction, and sleep disorders; OR Asymptomatic PHPT patients with any of the following conditions:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA)
Participants will undergo ultrasound-guided, non-surgical, non-thermal nanosecond pulse field ablation (nsPFA) of the targeted parathyroid gland using the nPulse™ system.
Incidence of Primary Safety Events (PSEs)
Time frame: From procedure through 6 months post-procedure
Normalization of corrected serum calcium and ionized calcium levels
Time frame: 6 months post-procedure
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 20 interventional studies with no phase under Hyperparathyroidism, Primary, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 84. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Primary →
Pulse Biosciences, Inc.