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

NCT07287176 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

  • Thyroid Nodule
  • Thyroid Goiter
  • Ablation

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.

Sponsors & Collaborators

  • Pulse Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Ralph Tufano, MD · Sarasota Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-21
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07287176 on ClinicalTrials.gov