ClinicalTrials.gg
Not yet recruitingNCT07912892VYBRANCE-PHPTUpdated Nov 3, 2026

Treating PHPT With the nPulse™ Vybrance™ PE System

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

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Primary Hyperparathyroidism

Keywords

  • nsPFA
  • Pulsed Field Ablation
03

In context

Hyperparathyroidism, Primary

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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 muscle weakness, dysfunction, and sleep disorders; OR Asymptomatic PHPT patients with any of the following conditions:

    1. Serum calcium is higher than the value by 1 mg/dL (0.25 mmol/L);
    2. 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 ( \< 60 mL/min);
    3. There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and/or radiographic evidence of fragility fractures;
    4. Age \< 50 years;
    5. 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 to participate in this study.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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 drug or device within 30 days and/or participants who are currently participating in another clinical trial.
Terms in these criteria, in plain language(4)

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.

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    nPulse Vybrance Percutaneous Electrode System Treatment Arm

    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)

Interventions

  • DeviceUltrasound-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.

06

What researchers measure

Primary outcomes

  1. Incidence of Primary Safety Events (PSEs)

    Time frame: From procedure through 6 months post-procedure

  2. Normalization of corrected serum calcium and ionized calcium levels

    Time frame: 6 months post-procedure

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Oct 28, 2026
First posted
Nov 3, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Nov 30, 2027
CompletionEst.
Jun 30, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07912892
Lead sponsor
Pulse Biosciences, Inc.
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Nov 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Ioana Gruchevska
Contact
ioana.gruchevska@pulsebiosciences.com
314-484-7033
Ralph Tufano, MD
principal investigator · Sarasota Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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