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RECRUITING
NCT07287176
NA

Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System

Sponsor: Pulse Biosciences, Inc.

View on ClinicalTrials.gov

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

Interventions

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.

Locations (2)

Sarasota Memorial Hospital

Sarasota, Florida, United States

Weill Cornell Medicine

New York, New York, United States