Health TrialsbyHealthPanel

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

ConditionsThyroid NoduleThyroid GoiterAblation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorPulse Biosciences, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is willing and able to provide voluntary, written informed consent to participate in this study and from whom written informed consent has been obtained

Participants must be willing and able to comply with study procedures including all follow-up visits

Selected nodule is amenable to trans-isthmus approach

(Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);

Disqualifiers

Participant has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter defibrillator)

Participant has cystic nodules (< 70% solid components)

Participant has calcified nodules

Participant is known to be immune compromised

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: nPulse Vybrance Percutaneous Electrode System Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Volume Reduction Ratio (VRR)

The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) using the nPulse Vybrance Percutaneous Electrode System

Time frame
6 months post-index procedure

Secondary outcomes

1

Volume Reduction Ratio (VRR) Over Time

The percentage decrease of thyroid nodule volume measured by ultrasonography after treatment (ablation) at various time points post-ablation using the nPulse Vybrance Percutaneous Electrode System

Time frame
1 month, 3 months, 6 months and 12 months post-nPulse Vybrance treatment
2

Recurrence Rate

The number of participants who experience nodule recurrence in same location of treatment post-nPulse Vybrance index procedure

Time frame
6 and 12 months post-nPulse Vybrance treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pulse Biosciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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