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New treatment option for Thyroid Nodule
Official title Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System
ClinicalTrials.gov ID: NCT07287176
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 80
You may be able to join if
- Participant is willing and able to provide voluntary, written informed consent to participate in this study and from whom written informed consent...
- 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:
- (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);
You likely can't join if
- 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
- Participant had previous neck irradiation
- Participant has abnormal cervical lymph nodes present during screening visit examination
See the full eligibility criteria
- 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
- Nodule is confirmed as benign based on results from one or more of the following diagnostic tests:
- (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]...
- 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
- 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
- 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
- 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...
- 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...
- Use of any investigational device or drug within 30 days prior to enrollment that may confound the results of this study
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.