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

Официальное название

Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN) Study

Обзор

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.

Подробное описание

The study design is a prospective, non-randomized, clinical study using the Pulse Biosciences nPulse Vybrance Percutaneous Electrode (PE) System for the treatment of benign thyroid nodules (BTNs) using nanosecond Pulsed Field Ablation (PFA). All participants will receive at least one nsPFA treatment and may be eligible to receive a second treatment at the 6-month follow up visit per physician discretion. All participants will have regularly scheduled ultrasound assessments and administration of questionnaires (e.g., Thy-PRO39 and SF-12) at 1-month, 3 months, 6 months and 12 months post-nsPFA treatment.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Volume Reduction Ratio (VRR) [Срок оценки: 6 months post-index procedure]

Вторичные конечные точки (2)

• Volume Reduction Ratio (VRR) Over Time [Срок оценки: 1 month, 3 months, 6 months and 12 months post-nPulse Vybrance treatment]
• Recurrence Rate [Срок оценки: 6 and 12 months post-nPulse Vybrance treatment]

Критерии участия

Критерии включения

• 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 \[ATA\] very low suspicion\];
• 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

Критерии исключения

• 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 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Sarasota Memorial Hospital — Sarasota
• NYU Langone Health — New York
• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT07287176 · NP-TF-US-038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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