Recruiting

nsPFA

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07218315

Conditions

Thyroid Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CellFX nsPFA Percutaneous Electrode System

Study Details

Brief summary:

This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T

Conditions

Thyroid Carcinoma

Study ID

NCT07218315

Start date

Feb 11, 2026

Status verified date

Jul, 2026

Completion date

Jan 31, 2031

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: ). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:

  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study procedure.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with nsPFA

Participants will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation.

Interventions

CellFX nsPFA Percutaneous Electrode System

Patients will undergo thyroid ablation with the CellFX nsPFA system, an outpatient procedure under local anesthesia, or intravenous sedation.

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Victoria E Banuchi, MPH

713-563-7600vebanuchi@mdanderson.org

Locations

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Ralph Tufano, MD

713-563-7600ralph-tufano@smh.com

Principal Investigator:

Ralph Tufano, MD

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Victoria E Banuchi, MPH

713-563-7600vebanuchi@mdanderson.org

Principal Investigator:

Victoria E Banuchi, MPH

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-07-30.