Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
NCT ID: NCT07287176
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-08-21
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
nPulse Vybrance Percutaneous Electrode System
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.
Interventions
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nPulse Vybrance Percutaneous Electrode System
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.
Eligibility Criteria
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Inclusion Criteria
* Participants must be willing and able to comply with study procedures including all follow-up visits
* Selected nodule is amenable to trans-isthmus approach
* Nodule is confirmed as benign based on results from one or more of the following diagnostic tests:
1. (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);
2. 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\];
3. Candidate has a hyperfunctional nodule following 1 ultrasound guided FNA or CNB with or without molecular testing; or
4. Benign (Bethesda III or IV) with two biopsies in addition to molecular testing confirming benign diagnosis
* Selected nodule is \<80.0 ml
* Participant has normal vocal cord mobility by ultrasound evaluation
* Participant has presence of compression symptoms, cosmetic concerns or anxiety for which participant requests treatment of the benign thyroid nodule
* Participant has a solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter
Exclusion Criteria
* Participant has cystic nodules (\< 70% solid components)
* Participant has calcified nodules
* Participant is known to be immune compromised
* Participant had previous neck irradiation
* Participant has abnormal cervical lymph nodes present during screening visit examination
* Participant has history of familial thyroid cancer in more than two first-degree relatives
* Selected nodule previously treated with radiofrequency ablation or ethanol. This does not apply to nodules previously treated with nanosecond Pulsed Field Ablation (nsPFA)
* Participants currently suffering from a hematological disease or bleeding tendency
* Selected nodule likely to be in contact with the recurrent laryngeal nerve on ultrasound evaluation
* Participant has a history of uncontrolled cardiac arrhythmia, uncontrolled hypertension, chronic liver disease or chronic kidney disease (Stage 4-5), or recent history of myocardial infarction or structural heart disease as determined by the Investigator
* Participant has abnormal contralateral vocal cord function
* Anesthesia drug allergies
* Participant is pregnant at the time of screening or within 30 days prior to enrollment
* Participant has any condition or situation which, in the Investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study
* Use of any investigational device or drug within 30 days prior to enrollment that may confound the results of this study
22 Years
80 Years
ALL
No
Sponsors
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Pulse Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ralph Tufano, MD
Role: PRINCIPAL_INVESTIGATOR
Sarasota Memorial Hospital
Locations
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Sarasota Memorial Hospital
Sarasota, Florida, United States
Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Natalia Belive, MS
Role: primary
Dana Whitehall
Role: primary
Other Identifiers
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NP-TF-US-038
Identifier Type: -
Identifier Source: org_study_id