RecruitingNot ApplicableNCT07287176

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

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


Sponsor

Pulse Biosciences, Inc.

Enrollment

100 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating a new device called the nPulse Vybrance system, which uses short electrical pulses to destroy benign (non-cancerous) thyroid nodules without surgery. **You may be eligible if...** - Your thyroid nodule has been confirmed as benign (non-cancerous) by at least one fine needle aspiration or biopsy, or two biopsies - Your nodule can be approached safely through a specific technique (trans-isthmus approach) - You are willing and able to attend all follow-up visits - You can provide written informed consent **You may NOT be eligible if...** - Your thyroid nodule has not been confirmed as benign - The nodule is not accessible for the required procedure technique - You have signs of cancer or suspicious features on ultrasound that have not been cleared by biopsy - You are not able to comply with study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEnPulse 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.


Locations(3)

Sarasota Memorial Hospital

Sarasota, Florida, United States

NYU Langone Health

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

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NCT07287176


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