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Study of nPulse™ Vybrance™ for Benign Thyroid Nodules

This study is evaluating the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System for treating benign (non-cancerous) thyroid nodules and goiters. The nPulse Vybrance system uses nanosecond Pulsed Field Ablation (nsPFA) to treat the nodule. You may be eligible if you are between 22 and 80 years old, have a benign thyroid nodule suitable for treatment, and are willing to attend follow-up appointments. The main goal is to see how much the thyroid nodule shrinks (Volume Reduction Ratio) after 6 months. This study aims to confirm results from an earlier study and will enroll 100 participants. The current recruitment status is unclear.

Study design
This is a prospective, non-randomized clinical study involving 100 participants. It uses the nPulse Vybrance Percutaneous Electrode System to treat benign thyroid nodules.
What's involved
You will receive at least one nsPFA treatment, potentially a second at 6 months. You will have regular ultrasound assessments and complete questionnaires at 1, 3, 6, and 12 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the nsPFA treatment, with the primary outcome measured at 6 months.

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NCT07287176

Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System

Recruiting
NAAges 22–80InterventionalTreatment
Pulse Biosciences, Inc.
~100 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:nPulse Vybrance Percutaneous Electrode System

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Volume Reduction Ratio (VRR)
Measured over 6 months post-index procedure

Conditions

Thyroid Nodule
Thyroid Goiter
Ablation

Explore related trials

GoiterThyroid Gland Nodule

Where it's being run

3 sites across 2 states
New York2
Florida1

Study leadership

  • Ralph Tufano, MD · PRINCIPAL_INVESTIGATOR · Sarasota Memorial Hospital

Who to contact

Ioana Gruchevska
[email protected]
(314) 484-7033
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Volume Reduction Ratio (VRR)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