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

NCT07287176 | Recruiting FDA Device

• 1 other identifier: NP-TF-US-038
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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; Ablation; Thyroid Goiter

Keywords

nsPFA; Pulsed Field Ablation

Outcome Measures

Primary Outcomes (1)

• Volume Reduction Ratio (VRR)

  The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) using the nPulse Vybrance Percutaneous Electrode System

  6 months post-index procedure

Secondary Outcomes (2)

• Volume Reduction Ratio (VRR) Over Time

  1 month, 3 months, 6 months and 12 months post-nPulse Vybrance treatment

• Recurrence Rate

  6 and 12 months post-nPulse Vybrance treatment

Study Arms (1)

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.

Device: nPulse Vybrance Percutaneous Electrode System

Interventions

nPulse Vybrance Percutaneous Electrode System DEVICE

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.

nPulse Vybrance Percutaneous Electrode System Treatment Arm

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (3)

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Goiter

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Ralph Tufano, MD

  Sarasota Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioana Gruchevska

CONTACT

(314) 484-7033; ioana.gruchevska@pulsebiosciences.com

William A. Knape

CONTACT

9197572033; bknape@pulsebiosciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a prospective, multicenter, single arm, non-randomized, feasibility study

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 17, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)