Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
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
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
Treatments tested in this trial
- nPulse Vybrance Percutaneous Electrode System
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov