Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN) Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Pulse Biosciences, Inc.
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Volume Reduction Ratio (VRR)
Overview
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.
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
nPulse Vybrance Percutaneous Electrode System Treatment Arm
Adult participants who are clinically symptomatic will receive ablation of the benign thyroid nodule using the nPulse Vybrance Percutaneous Electrode System.
Intervention: nPulse Vybrance Percutaneous Electrode System (Device)
Outcomes
Primary Outcomes
Volume Reduction Ratio (VRR)
Time Frame: 6 months post-index procedure
The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) using the nPulse Vybrance Percutaneous Electrode System
Secondary Outcomes
- 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)