Recruiting

Observational Study

Sponsor:

Pulse Biosciences, Inc.

Code:

NCT07287176

Conditions

Thyroid Nodule

Thyroid Goiter

Ablation

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

nPulse Vybrance Percutaneous Electrode System

Study Details

Brief summary:

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.

Conditions

Thyroid Nodule

Thyroid Goiter

Ablation

Study ID

NCT07287176

Start date

Aug 21, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Volume Reduction Ratio (VRR) [ Time Frame: 6 months post-index procedure ]

Central Contacts and Locations

Locations

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Keilee Luo, MS, CCRC

keilee.luo@nyulangone.org

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

More Information

Sponsor

Pulse Biosciences, Inc.

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

  • nsPFA
  • Pulsed Field Ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pulse Biosciences, Inc. on 2026-04-15.