CellFX ® Percutaneous Electrode (PE) Treatment of Benign Thyroid Nodules

Pulse Biosciences

Status

Enrolling

Conditions

Thyroid Nodule (Benign)

Treatments

Device: CellFX® Percutaneous Electrode (PE) System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06117085

NP-TF-024

Details and patient eligibility

About

The objective of this clinical feasibility study is to evaluate initial clinical safety and device performance of the CellFX Percutaneous Electrode (PE) System for the treatment of symptomatic benign thyroid nodules.

Full description

Cohort 1: (CellFX PE Procedure and Surgery) The first five enrolled subjects will be patients with planned thyroidectomy. The site investigator will perform the CellFX procedure followed by an ultrasound evaluation. The site investigator will then perform a partial or total thyroidectomy. Tissue samples from the CellFX targeted treated areas will be sent to the pathology lab for gross and histological evaluation. The participant will exit the study on the same day of surgery.

Cohort 2: (CellFX PE Procedure with 12 months follow-up) When Cohort 1 is completed, up to 25 subjects will undergo a CellFX treatment using a percutaneous approach under ultrasound guidance. After CellFX treatment, all subjects will be followed weekly until 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant must be at least 18 or no older than 80 years of age
Participant gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Participant must comply with study procedures including all follow-up visits diagnosis of thyroid nodule confirmed by ultrasonography ≤Grade 3 (2017 ACR TI-RADS and fine needle aspiration biopsy FNA (Bethesda category II ) with no macro-calcifications in target nodule within 30 days of enrollment
Participant has single nodule ≤ 6.0 cm in greatest dimension.
Participant may have abnormal thyroid function, such as suppressed thyrotropin (TSH) levels, at the screening visit
Participant has no abnormal cervical lymph nodes during screening visit examination
Participant has thyroid nodule causing appearance, pressure or swallowing symptoms
Participant has absence of abnormal vocal cord mobility by ultrasound evaluation

Exclusion criteria

Participant has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter defibrillator)
Participant has an active systemic infection on the day of the CellFX PE procedure with either fever, leukocytosis or requiring intravenous antibiotics or history of head and neck, pulmonary or systemic infection in the last 2 weeks prior to CellFX PE procedure
Participant is known to be immune compromised
Participant is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study
Participant had previous neck irradiation
Participant has history of familial thyroid cancer in more than two first-degree relatives
Participants currently suffering from hematological diseases or bleeding tendency, or patients currently requiring continuous administration of antiplatelet and anticoagulant drugs
Ultrasonographic evidence of calcifications, irregular margins or sonographic features that are suspicious for malignancy
Nodule likely to be in contact with the recurrent laryngeal nerve on ultrasound evaluation
History of cardiac arrhythmia, uncontrolled hypertension, liver or kidney disease, or recent history of myocardial infarctions or structural heart disease as determined by the Investigator
History of a coagulation mechanism disorder or bleeding tendency
Abnormal contralateral vocal cord function
Allergy or contraindication to assigned analgesia/anesthesia
Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period
Have 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 other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study