Thyroid NodulePRECISE-BTNNCT07287176
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
A study testing nPulse Vybrance Percutaneous Electrode System in people with Thyroid Nodule and Thyroid Goiter, run by Pulse Biosciences, Inc. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Thyroid Nodule, Thyroid Goiter, Ablation
- What is being tested?
- nPulse Vybrance Percutaneous Electrode System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Aug 2025to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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];
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NYU Langone Health
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10065
Sarasota Memorial Hospital
Sarasota, Florida, 34239
About this study
Official title: Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN)
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.
Read the detailed description
The study design is a prospective, non-randomized, clinical study using the Pulse Biosciences nPulse Vybrance Percutaneous Electrode (PE) System for the treatment of benign thyroid nodules (BTNs) using nanosecond Pulsed Field Ablation (PFA). All participants will receive at least one nsPFA treatment and may be eligible to receive a second treatment at the 6-month follow up visit per physician discretion. All participants will have regularly scheduled ultrasound assessments and administration of questionnaires (e.g., Thy-PRO39 and SF-12) at 1-month, 3 months, 6 months and 12 months post-nsPFA treatment.
- Conditions
- Thyroid Nodule, Thyroid Goiter, Ablation
- Being tested
- nPulse Vybrance Percutaneous Electrode System
- Keywords
- nsPFA, Pulsed Field Ablation
- Medical subject headings
- Thyroid Nodule, Goiter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nPulse Vybrance Percutaneous Electrode SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| nPulse Vybrance Percutaneous Electrode System Treatment Arm | Experimental | Adult participants who are clinically symptomatic will receive ablation of the benign thyroid nodule using the nPulse Vybrance Percutaneous Electrode System. Receives: Device: nPulse Vybrance Percutaneous Electrode System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thyroid nodule volume reduction
measured by ultrasonography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start21 Aug 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, multicenter, single arm, non-randomized study
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralph Tufano, MD, Principal investigator, Sarasota Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287176
- Sponsor's protocol ID
- NP-TF-US-038
- Acronym
- PRECISE-BTN
- Status last verified
- Oct 2026
- First submitted
- 11 Dec 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN)
- ClinicalTrials.gov ID
- NCT07287176
- Acronym / sponsor ID
- PRECISE-BTN / NP-TF-US-038
- Conditions
- Thyroid Nodule, Thyroid Goiter, Ablation
- Keywords
- nsPFA, Pulsed Field Ablation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study design is a prospective, non-randomized, clinical study using the Pulse Biosciences nPulse Vybrance Percutaneous Electrode (PE) System for the treatment of benign thyroid nodules (BTNs) using nanosecond Pulsed Field Ablation (PFA). All participants will receive at least one nsPFA treatment and may be eligible to receive a second treatment at the 6-month follow up visit per physician discretion. All participants will have regularly scheduled ultrasound assessments and administration of questionnaires (e.g., Thy-PRO39 and SF-12) at 1-month, 3 months, 6 months and 12 months post-nsPFA treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, multicenter, single arm, non-randomized study
| Arm | Type | Receives |
|---|---|---|
| nPulse Vybrance Percutaneous Electrode System Treatment Arm | Experimental | Device: nPulse Vybrance Percutaneous Electrode SystemAdult participants who are clinically symptomatic will receive ablation of the benign thyroid nodule using the nPulse Vybrance Percutaneous Electrode System. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nPulse Vybrance Percutaneous Electrode SystemThe 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. | Device | nPulse Vybrance Percutaneous Electrode System Treatment Arm |
Primary outcome
Thyroid nodule volume reduction
Time frame: 6 months
measured by ultrasonography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Tufano, MD principal investigator
Sarasota Memorial Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nPulse Vybrance Percutaneous Electrode System in people with Thyroid Nodule and Thyroid Goiter, run by Pulse Biosciences, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thyroid nodule volume reduction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.