RecruitingNot Applicable

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

United States100 participantsStarted 2025-08-21

Plain-language 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.

Who can participate

Age range22 Years – 80 Years

SexALL

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Inclusion criteria

✓. (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);
✓. A single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features \[American College of Radiology (ACR) Thyroid Imaging Reporting \& Data System \[TI-RAD\] TR 1-3, American Thyroid Association \[ATA\] very low suspicion\];
✓. Candidate has a hyperfunctional nodule following 1 ultrasound guided FNA or CNB with or without molecular testing; or
✓. Benign (Bethesda III or IV) with two biopsies in addition to molecular testing confirming benign diagnosis

What they're measuring

Volume Reduction Ratio (VRR)

Timeframe: 6 months post-index procedure

Trial details

NCT IDNCT07287176

SponsorPulse Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Ioana Gruchevska

(314) 484-7033 ioana.gruchevska@pulsebiosciences.com

View on ClinicalTrials.gov More Thyroid Nodule trials