Treating PHPT With the nPulse™ Vybrance™ PE System (VYBRANCE-PHPT)

October 28, 2026 updated by: Pulse Biosciences, Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Health Care System
        • Principal Investigator:
          • Ralph Tufano, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 upper limit of the normal 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 (glomerular filtration rate < 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 informed consent to participate in this study.

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 investigational drug or device within 30 days and/or participants who are currently participating in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

Participants will undergo ultrasound-guided, non-surgical, non-thermal nanosecond pulse field ablation (nsPFA) of the targeted parathyroid gland using the nPulse™ system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Primary Safety Events (PSEs)
Time Frame: From procedure through 6 months post-procedure
From procedure through 6 months post-procedure
Normalization of corrected serum calcium and ionized calcium levels
Time Frame: 6 months post-procedure
6 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pulse Biosciences, Inc.

Investigators

  • Principal Investigator: Ralph Tufano, MD, Sarasota Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

October 28, 2026

First Submitted That Met QC Criteria

October 28, 2026

First Posted (Actual)

November 3, 2026

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 28, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP-PARAF-US-046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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