Primary HyperparathyroidismVYBRANCE-PHPTNCT07912892
Treating PHPT With the nPulse™ Vybrance™ PE System
A study testing Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA) in people with Primary Hyperparathyroidism, run by Pulse Biosciences, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Primary Hyperparathyroidism
- What is being tested?
- Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 muscle weakness, dysfunction, and sleep disorders; OR Asymptomatic PHPT patients with any of the following conditions:
- Serum calcium is higher than the upper limit of the normal value by 1 mg/dL (0.25 mmol/L);
- There is objective evidence of renal involvement, including asymptomatic kidney stones, nephrocalcinosis, hypercalciuria (24 - hour urinary calcium level > 250mg/dL for women and >300mg/dl for men), on renal imaging, or impaired renal function (glomerular filtration rate < 60 mL/min);
- There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and/or radiographic evidence of fragility fractures;
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- Age < 50 years;
- The participant is willing and able to comply with study procedures including all follow-up visits. Patient desires an intervention but doesn't want surgery
- One diseased parathyroid gland (≥ 1cm in greatest dimension), by ultrasonography and four-phase CT scan.
- The diseased targeted parathyroid gland is accessible for nsPFA treatment.
- Participants are willing and able to provide voluntary, written informed consent to participate in this study.
Who cannot join
- Participants have an implantable electronic medical device (i.e., pacemaker, implantable cardioverter defibrillator).
- Diagnosis of secondary or tertiary hyperparathyroidism.
- Known spondylitis of the neck vertebrae.
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of previous thyroid or parathyroid surgery or ablation for a neoplasm in the neck region.
- History of neck irradiation.
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- Anesthesia drug allergies.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit(s).
- Participants are pregnant at the time of screening or within 30 days prior to enrollment.
- Participants who have received any investigational drug or device within 30 days and/or participants who are currently participating in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Emily Brimblecom, 941-917-2225, ResearchInstitute@smh.com
Ralph Tufano, MD
About this study
Official title: Clinical Evaluation of the nPulse™ VYBRANCE™ Percutaneous Electrode System in Treating Primary Hyperparathyroidism
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.
Read the detailed description
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.
- Conditions
- Primary Hyperparathyroidism
- Being tested
- Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA)
- Keywords
- nsPFA, Pulsed Field Ablation
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA)Device
Participants will undergo ultrasound-guided, non-surgical, non-thermal nanosecond pulse field ablation (nsPFA) of the targeted parathyroid gland using the nPulse™ system.
| Study group | Role | What they receive |
|---|---|---|
| nPulse Vybrance Percutaneous Electrode System Treatment Arm | Experimental | 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. Receives: Device: Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Primary Safety Events (PSEs)
Measured: From procedure through 6 months post-procedure
Normalization of corrected serum calcium and ionized calcium levels
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Tufano, MD, Principal investigator, Sarasota Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912892
- Sponsor's protocol ID
- NP-PARAF-US-046
- Acronym
- VYBRANCE-PHPT
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the nPulse™ VYBRANCE™ Percutaneous Electrode System in Treating Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT07912892
- Acronym / sponsor ID
- VYBRANCE-PHPT / NP-PARAF-US-046
- Conditions
- Primary Hyperparathyroidism
- Keywords
- nsPFA, Pulsed Field Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nPulse Vybrance Percutaneous Electrode System Treatment Arm | Experimental | Device: Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 muscle weakness, dysfunction, and sleep disorders; OR Asymptomatic PHPT patients with any of the following conditions:
- One diseased parathyroid gland (≥ 1cm in greatest dimension), by ultrasonography and four-phase CT scan.
- The diseased targeted parathyroid gland is accessible for nsPFA treatment.
Key exclusion criteria (10 listed)
- Participants have an implantable electronic medical device (i.e., pacemaker, implantable cardioverter defibrillator).
- Diagnosis of secondary or tertiary hyperparathyroidism.
- Known spondylitis of the neck vertebrae.
- Head and/or neck disease that prevents hyperextension of neck.
- Known history of previous thyroid or parathyroid surgery or ablation for a neoplasm in the neck region.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | nPulse Vybrance Percutaneous Electrode System Treatment Arm |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ralph Tufano, MD principal investigator
Sarasota Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Parathyroid Nanosecond Pulsed Field Ablation (nsPFA) in people with Primary Hyperparathyroidism, run by Pulse Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ioana Gruchevska (314-484-7033, ioana.gruchevska@pulsebiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Primary Safety Events (PSEs) (time frame: From procedure through 6 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.