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Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
Sponsor: Pulse Biosciences, Inc.
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.
Official title: Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN) Study
Key Details
Gender
All
Age Range
22 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-08-21
Completion Date
2027-02
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (2)
Sarasota Memorial Hospital
Sarasota, Florida, United States
Weill Cornell Medicine
New York, New York, United States