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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Pulse Biosciences, Inc.
Study ID
NCT07287176
Status
Recruiting
Apply to this trial

Conditions

  • Ablation
  • Thyroid Goiter
  • Thyroid Nodule

Eligibility Criteria

Sex
ALL
Age
22 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • nPulse Vybrance Percutaneous Electrode System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 21, 2025
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nPulse Vybrance Percutaneous Electrode System Treatment Arm
    Adult participants who are clinically symptomatic will receive ablation of the benign thyroid nodule using the nPulse Vybrance Percutaneous Electrode System.

Primary Outcome Measure

Volume Reduction Ratio (VRR) [ Time Frame: 6 months post-index procedure ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Sarasota Memorial HospitalSarasotaFlorida34239
Natalia Belive, MS
[email protected]
941-917-1299
NYU Langone HealthNew YorkNew York10016
Keilee Luo, MS, CCRC
[email protected]
Weill Cornell MedicineNew YorkNew York10065
Dana Whitehall
[email protected]

Find similar trials in Sarasota, FL

By research site
Sarasota Memorial Hospital· Sarasota, FLNYU Langone Health· New York, NYWeill Cornell Medicine· New York, NY

Related Studies