Pulse Biosciences nPulse Vybrance percutaneous electrode for treating benign thyroid nodules with nanosecond pulsed field ablation

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

This trial tests the nPulse Vybrance nanosecond pulsed field ablation device to shrink benign thyroid nodules and improve symptoms and quality of life in adults with confirmed benign nodules.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 22 Years to 80 Years
• Sex: All
• Sponsor: Pulse Biosciences, Inc. (Industry-sponsored)
• Locations: 3 sites (Sarasota, Florida and 2 other locations)
• Trial ID: NCT07287176 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-randomized, multi-center clinical study using the Pulse Biosciences nPulse Vybrance percutaneous electrode to deliver nanosecond pulsed field ablation (nsPFA) to benign thyroid nodules. All participants receive at least one nsPFA treatment and may be offered a second treatment at the 6-month visit at the physician's discretion. Patients undergo scheduled ultrasound evaluations and complete validated quality-of-life questionnaires (ThyPRO-39 and SF-12) at 1, 3, 6, and 12 months after treatment. The primary aim is to reproduce results from a prior First‑In‑Human feasibility experience and to monitor nodule response, thyroid-related symptoms, and patient-reported quality of life.

Who should consider this trial

Good fit: Adults with symptomatic benign thyroid nodules confirmed by biopsy or benign imaging features whose nodules are accessible via a trans‑isthmus approach are the intended candidates.

Not a fit: Patients with nodules suspicious for malignancy, those not amenable to a trans‑isthmus approach, or those who require or prefer surgical thyroidectomy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, this device could provide a minimally invasive, non-thermal option to reduce nodule size and relieve symptoms without conventional surgery.

How similar studies have performed: A single First‑In‑Human feasibility study reported promising initial results, but broader multi-center confirmation is currently limited.

Eligibility criteria

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

Where this trial is running

Sarasota, Florida and 2 other locations

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

Study contacts

• Principal investigator: Ralph Tufano, MD — Sarasota Memorial Hospital
• Study coordinator: Ioana Gruchevska

Conditions Thyroid Nodule; Thyroid Goiter; Ablation; nsPFA; Pulsed Field Ablation