NCT07287176

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Nodule
• Thyroid Goiter
• Ablation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-21
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2025-12-17
• Last updated: 2026-04-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study