Actively Recruiting
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
Led by Pulse Biosciences, Inc. · Updated on 2026-04-15
100
Participants Needed
3
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Willing and able to comply with all study procedures including follow-up visits
- Selected thyroid nodule can be approached trans-isthmus
- Nodule confirmed benign by at least two fine needle aspirations or core needle biopsies, or one biopsy with benign ultrasound features, or hyperfunctional nodule diagnosis, or benign diagnosis verified by molecular testing
- Selected nodule volume is less than 80.0 ml
- Normal vocal cord movement confirmed by ultrasound
- Presence of compression symptoms, cosmetic concerns, or anxiety leading to treatment request
- Solitary thyroid nodule or dominant nodule in multinodular goiter, well defined
You will not qualify if you...
- Presence of implantable electronic medical device (e.g., pacemaker, defibrillator)
- Nodules with less than 70% solid component (cystic nodules)
- Calcified nodules
- Known immune compromise
- Previous neck radiation treatment
- Abnormal cervical lymph nodes at screening
- Family history of thyroid cancer in more than two first-degree relatives
- Nodule previously treated with radiofrequency ablation or ethanol
- Current hematological disease or bleeding tendency
- Nodule likely contacting recurrent laryngeal nerve
- History of uncontrolled cardiac arrhythmia, hypertension, chronic liver or kidney disease (Stage 4-5), recent myocardial infarction or structural heart disease
- Abnormal vocal cord function on the opposite side
- Allergies to anesthesia drugs
- Pregnant or within 30 days prior to enrollment
- Any condition or situation that poses significant risk, confounds study results, or interferes with participation
- Use of investigational device or drug within 30 days before enrollment that may affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
2
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
3
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
Research Team
I
Ioana Gruchevska
CONTACT
W
William A. Knape
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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