nPulse Vybrance for Thyroid Nodules

(PRECISE-BTN Trial)

Recruiting at 1 trial location

Overseen By Ioana Gruchevska

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pulse Biosciences, Inc.

Disqualifiers: Implantable devices, Immune compromised, Neck irradiation, Hematological disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the nPulse Vybrance Percutaneous Electrode System for individuals with benign thyroid nodules. The researchers aim to determine if this treatment can effectively reduce symptoms and improve quality of life by shrinking the nodules. The trial seeks participants with a benign thyroid nodule causing discomfort, cosmetic concerns, or anxiety, who have not undergone treatments like radiofrequency ablation.

As an unphased trial, it provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using any investigational drugs or devices, you must stop them at least 30 days before joining the trial.

What prior data suggests that the nPulse Vybrance Percutaneous Electrode System is safe for treating thyroid nodules?

Research has shown that the nPulse Vybrance Percutaneous Electrode System is safe and effective for treating non-cancerous thyroid nodules. In earlier studies, participants generally tolerated this treatment well, with no reports of serious side effects. The system uses nanosecond pulsed field ablation (nsPFA), a special type of energy under study for its safety. Although more research is needed, early results are promising and suggest that the system sets a new standard for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for thyroid nodules, which often include surgery or radioactive iodine therapy, the nPulse Vybrance Percutaneous Electrode System offers a minimally invasive approach. This system uses targeted ablation to specifically treat benign thyroid nodules, potentially reducing the need for more invasive procedures. Researchers are excited about this treatment because it promises precision and efficiency, potentially leading to quicker recovery times and fewer complications for patients.

What evidence suggests that the nPulse Vybrance Percutaneous Electrode System is effective for thyroid nodules?

Research has shown that the nPulse Vybrance Percutaneous Electrode System, which participants in this trial will receive, could effectively treat non-cancerous thyroid nodules. Early results from a study found that it reduced nodule size by up to 93% without causing internal scarring, as seen in follow-up ultrasounds. This treatment can shrink nodules without harming surrounding tissue. The system uses a special needle to deliver energy directly to the nodule, potentially reducing symptoms caused by thyroid nodules. These findings offer promising new treatment options for people with benign thyroid nodules. ^{1 4 6 7 8}

Who Is on the Research Team?

Ralph Tufano, MD

Principal Investigator

Sarasota Memorial Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with thyroid nodules, hyperthyroidism, goiter, or needing an ablation procedure. Specific eligibility criteria are not provided in the given information.

Inclusion Criteria

Nodule is confirmed as benign based on specific diagnostic tests

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

I am willing and able to follow the study's required procedures and attend all follow-up visits.

Exclusion Criteria

Participant is known to be immune compromised

I have had radiation therapy to my neck before.

I have abnormal lymph nodes in my neck.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive at least one nsPFA treatment for benign thyroid nodules using the nPulse Vybrance Percutaneous Electrode System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness with ultrasound assessments and questionnaires at 1, 3, 6, and 12 months post-treatment

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• nPulse Vybrance Percutaneous Electrode System

Trial Overview

The study tests the nPulse Vybrance Percutaneous Electrode System on patients with thyroid conditions to see if it can replicate previous positive results and improve quality of life post-ablation.

How Is the Trial Designed?

Group I: nPulse Vybrance Percutaneous Electrode System Treatment Arm Experimental Treatment 1 Intervention

Adult participants who are clinically symptomatic will receive ablation of the benign thyroid nodule using the nPulse Vybrance Percutaneous Electrode System.

Who Is Running the Clinical Trial?

Pulse Biosciences, Inc.

Lead Sponsor

Trials

11

Recruited

850+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07287176

Prospective Evaluation of the Pulse Biosciences nPulse™ ...

Adult participants who are clinically symptomatic will receive ablation of the benign thyroid nodule using the nPulse Vybrance Percutaneous ...

2.

investors.pulsebiosciences.com

investors.pulsebiosciences.com/news-releases/news-release-details/pulse-biosciences-reports-business-updates-and-third-quarter-1

Pulse Biosciences Reports Business Updates and Third ...

Initiated a multi-center clinical study, PRECISE-BTN, for the treatment of benign thyroid nodules (BTN) with the nPulse Vybrance percutaneous ...

3.

biospace.com

biospace.com/press-releases/pulse-biosciences-inc-announces-initiation-of-research-collaboration-for-the-treatment-of-benign-and-malignant-thyroid-tumors-with-npulse-technology

Pulse Biosciences, Inc. Announces Initiation of Research ...

The Company's nPulse Vybrance Percutaneous Electrode System consists of a percutaneous needle electrode for use with the Company's proprietary ...

4.

businesswire.com

businesswire.com/news/home/20250826989474/en/Pulse-Biosciences-Announces-Publication-of-First-In-Human-Data-for-Treatment-of-Benign-Thyroid-Nodules-in-the-Journal-Thyroid

Pulse Biosciences Announces Publication of First-In- ...

Results showed no intranodular fibrosis or scarring on follow-up ultrasounds and fully treated nodules (Cohort 3) had up to 93% reduction in ...

5.

investing.com

investing.com/news/company-news/pulse-biosciences-to-begin-thyroid-cancer-treatment-study-in-2026-93CH-4398273

Pulse Biosciences to begin thyroid cancer treatment study ...

Preclinical studies are also ongoing to evaluate the technology's effect on anaplastic thyroid carcinoma, which has a five-year survival rate of ...

6.

investors.pulsebiosciences.com

investors.pulsebiosciences.com/news-releases/news-release-details/pulse-biosciences-npulsetm-technology-be-featured-american

Press Release - Pulse Biosciences Inc.

“We believe the differentiated nPulse Vybrance Percutaneous Electrode system is setting a new standard for safety, efficacy, and workflow ...

7.

medicaldevice-network.com

medicaldevice-network.com/news/pulse-npulse-thyroid/

Pulse Biosciences, MD Anderson to study nPulse for ...

These studies are focused on assessing the impact of nanosecond pulsed field ablation (nsPFA) energy on anaplastic thyroid carcinoma. The nPulse ...

8.

nasdaq.com

nasdaq.com/articles/plse-starts-research-work-npulse-technology-treat-thyroid-tumor

PLSE Starts Research Work on nPulse Technology to Treat ...

Pulse Biosciences partners with MD Anderson to study its nPulse technology for treating benign and malignant thyroid tumors upon receiving ...