Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System (PRECISE-BTN)

April 13, 2026 updated by: Pulse Biosciences, Inc.

Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN) Study

The primary objective of this study is to reproduce in a multi-center study results obtained during the feasibility First-In-Human (FIH) study with Prof. Stefano Spiezia, MD (Ospedale del Mare, Naples, Italy) and to monitor additional thyroid-related symptoms and impact of patients quality of life post-ablation using a validated QoL questionnaire.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study design is a prospective, non-randomized, clinical study using the Pulse Biosciences nPulse Vybrance Percutaneous Electrode (PE) System for the treatment of benign thyroid nodules (BTNs) using nanosecond Pulsed Field Ablation (PFA). All participants will receive at least one nsPFA treatment and may be eligible to receive a second treatment at the 6-month follow up visit per physician discretion. All participants will have regularly scheduled ultrasound assessments and administration of questionnaires (e.g., Thy-PRO39 and SF-12) at 1-month, 3 months, 6 months and 12 months post-nsPFA treatment.

Study Type

Interventional

Enrollment (Estimated)

100

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 Contact Backup

Study Locations

  • United States
    • Florida
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Hospital
        • Contact:
    • New York
      • New York, New York, United States, 10065
      • New York, New York, United States, 10016

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant is willing and able to provide voluntary, written informed consent to participate in this study and from whom written informed consent has been obtained
  • Participants must be willing and able to comply with study procedures including all follow-up visits
  • Selected nodule is amenable to trans-isthmus approach

  • Nodule is confirmed as benign based on results from one or more of the following diagnostic tests:

    1. (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);
    2. A single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features [American College of Radiology (ACR) Thyroid Imaging Reporting & Data System [TI-RAD] TR 1-3, American Thyroid Association [ATA] very low suspicion];
    3. Candidate has a hyperfunctional nodule following 1 ultrasound guided FNA or CNB with or without molecular testing; or
    4. Benign (Bethesda III or IV) with two biopsies in addition to molecular testing confirming benign diagnosis
  • Selected nodule is <80.0 ml
  • Participant has normal vocal cord mobility by ultrasound evaluation
  • Participant has presence of compression symptoms, cosmetic concerns or anxiety for which participant requests treatment of the benign thyroid nodule
  • Participant has a solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter

Exclusion Criteria:

  • Participant has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter defibrillator)
  • Participant has cystic nodules (< 70% solid components)
  • Participant has calcified nodules
  • Participant is known to be immune compromised
  • Participant had previous neck irradiation
  • Participant has abnormal cervical lymph nodes present during screening visit examination
  • Participant has history of familial thyroid cancer in more than two first-degree relatives
  • Selected nodule previously treated with radiofrequency ablation or ethanol. This does not apply to nodules previously treated with nanosecond Pulsed Field Ablation (nsPFA)
  • Participants currently suffering from a hematological disease or bleeding tendency
  • Selected nodule likely to be in contact with the recurrent laryngeal nerve on ultrasound evaluation
  • Participant has a history of uncontrolled cardiac arrhythmia, uncontrolled hypertension, chronic liver disease or chronic kidney disease (Stage 4-5), or recent history of myocardial infarction or structural heart disease as determined by the Investigator
  • Participant has abnormal contralateral vocal cord function
  • Anesthesia drug allergies
  • Participant is pregnant at the time of screening or within 30 days prior to enrollment
  • Participant has any condition or situation which, in the Investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study
  • Use of any investigational device or drug within 30 days prior to enrollment that may confound the results of this study

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
Adult participants who are clinically symptomatic will receive ablation of the benign thyroid nodule using the nPulse Vybrance Percutaneous Electrode System.
Device: nPulse Vybrance Percutaneous Electrode System
The nPulse Vybrance procedure will be performed under ultrasonographic guidance using a local anesthetic at the intended puncture site and all participants will receive general anesthesia in the operating room. The targeted thyroid nodule will be treated within a customized treatment level (DEFAULT) programmed on the Console. The Investigator will treat the entire nodule while protecting from ablation to any surrounding vital structures to prevent serious adverse events throughout the procedure. Any procedural adverse events will be documented, as applicable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume Reduction Ratio (VRR)
Time Frame: 6 months post-index procedure
The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) using the nPulse Vybrance Percutaneous Electrode System
6 months post-index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume Reduction Ratio (VRR) Over Time
Time Frame: 1 month, 3 months, 6 months and 12 months post-nPulse Vybrance treatment
The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) at various time points post-ablation using the nPulse Vybrance Percutaneous Electrode System
1 month, 3 months, 6 months and 12 months post-nPulse Vybrance treatment
Recurrence Rate
Time Frame: 6 and 12 months post-nPulse Vybrance treatment
The number of participants who experience nodule recurrence in same location of treatment post-nPulse Vybrance index procedure
6 and 12 months post-nPulse Vybrance treatment

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 (Actual)

August 21, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP-TF-US-038

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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