Not a traditional drug phase: CellFX nsPFA Percutaneous Electrode System for Thyroid Carcinoma
This study is to measure the effectiveness of nsPFA in treating papillary thyroid microcarcinoma.
Official registry: https://clinicaltrials.gov/study/NCT07218315 · M.D. Anderson Cancer Center · enrollment listed as 15
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are CellFX nsPFA Percutaneous Electrode System. The registry lists allocation as na. This study is to measure the effectiveness of nsPFA in treating papillary thyroid microcarcinoma.
They plan to enroll about 15 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma
Interventions: CellFX nsPFA Percutaneous Electrode System
Primary outcome (registry wording): Safety and Adverse Events (AEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- Ultrasonographic evaluation of tumor to be ablated must show size of less than or equal to 1.5 cm and no extrathyroidal extension or locoregional metastases
- Participant must have normal complete blood count, blood coagulation profile, and thyroid function test
- For females of childbearing potential, a negative serum or urine pregnancy test must be obtained at baseline, prior to the procedure
- Postmenopausal (no menses in greater than or equal to 12 consecutive months)
Who the registry excludes
- 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
- Participant has any condition or situation, in the opinion of the site Investigator, that puts the subject at significant risk, could confound the study results, or may interfere significantly with subject's participation in the study
Public study contact (from the registry)
Victoria E Banuchi, MPH
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
2 listed- Sarasota Memorial Hospital — Sarasota, Florida (recruiting)
- The University of Texas M. D. Anderson Cancer Center — Houston, Texas (recruiting)
FAQ about this NCT record
Is NCT07218315 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07218315?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07218315?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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