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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
Sarasota Memorial Hospital
Sarasota, Florida, United States
RECRUITINGWeill Cornell Medicine
New York, New York, United States
RECRUITINGVolume Reduction Ratio (VRR)
The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) using the nPulse Vybrance Percutaneous Electrode System
Time frame: 6 months post-index procedure
Volume Reduction Ratio (VRR) Over Time
The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) at various time points post-ablation using the nPulse Vybrance Percutaneous Electrode System
Time frame: 1 month, 3 months, 6 months and 12 months post-nPulse Vybrance treatment
Recurrence Rate
The number of participants who experience nodule recurrence in same location of treatment post-nPulse Vybrance index procedure
Time frame: 6 and 12 months post-nPulse Vybrance treatment
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