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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 employ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with serious adverse device effects
Timeframe: 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure
2
Number of Participants with Acute nodular volume loss