NCT07287176 · Pulse Biosciences, Inc.
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
(PRECISE-BTN)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- (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
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
- Sarasota, Florida
- New York, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations