Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
ConditionThyroid Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must provide voluntary, written informed consent to participate in this clinical investigation.
Participant agrees to comply with all study procedures, including all follow-up visits.
Participant with a Bethesda VI cytology (tumor size <= 1.5 cm, no known regional/distant metastases)
Participant with a Bethesda V cytology and normal calcitonin levels.
Disqualifiers
FNA findings suggestive of high-grade malignancy
Presence of regional or distant lymph node metastases.
Participant had a history of previous neck irradiation.
Females who are pregnant at time of enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
CellFX nsPFA Percutaneous Electrode System
DevicePatients will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Treatment with nsPFAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov