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

Recruiting now · Not applicable

Conditions studied: Thyroid Nodule, Thyroid Goiter, Ablation

In brief

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.

Key facts

Study ID: NCT07287176
Run by: Pulse Biosciences, Inc.
People needed: 100
Starts: 2025-08-21
Expected to finish: 2027-06-30
Last updated by the study team: 2026-04-15

Who can join

Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
(Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);
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];
Candidate has a hyperfunctional nodule following 1 ultrasound guided FNA or CNB with or without molecular testing; or
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

You may not qualify if…

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

Where it is running

Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
NYU Langone Health — New York, New York, United States (enrolling)
Weill Cornell Medicine — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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