An interventional study of nPulse Vybrance Percutaneous Electrode System in Thyroid Nodule, Thyroid Goiter and Ablation, sponsored by Pulse Biosciences, Inc.. Active, not recruiting at 3 sites in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Pulse Biosciences, Inc. · Not applicable, Interventional, and Treatment
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.
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.
207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.
This study's enrollment of 103 is above the median of 75 across 121 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Pulse Biosciences, Inc. is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Nodule is confirmed as benign based on results from one or more of the following diagnostic tests:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Thyroid nodule volume reduction
measured by ultrasonography
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Apr 2027, 20 months after the start.
Of 71 interventional studies with no phase under Thyroid Nodule, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's planned 20 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 28, 2026: primary completion Jun 2026 → Apr 2027 and completion Jun 2027 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pulse Biosciences, Inc.