ClinicalTrials.gg
RecruitingNCT07218315Updated Nov 9, 2026

Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma

An interventional study of CellFX nsPFA Percutaneous Electrode System in Thyroid Carcinoma, sponsored by M.D. Anderson Cancer Center. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Primary Objective:

To evaluate the efficacy of ultrasound-guided nsPFA™ in the treatment of patients with T1N0M0 PTC as measured by the thyroid nodule volume changes including volume reduction rate (VRR), technique efficacy (TE) and nodule regrowth (NR) during post procedure follow-up.

Secondary Objectives:

To assess the clinical safety and complications of the CellFX Percutaneous Electrode (PE) System

To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA.

To determine the health-related quality of life changes over time induced by ultrasound-guided nsPFA.

02

Conditions studied

  • Thyroid Carcinoma

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03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 15 is below the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant must provide voluntary, written 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 )
  • 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 , 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 (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:

    • (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 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

Exclusion Criteria:

  • FNA findings suggestive of high-grade
  • Presence of regional or distant lymph node .
  • 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Treatment with nsPFA

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

    Device: CellFX nsPFA Percutaneous Electrode System

Interventions

  • DeviceCellFX nsPFA Percutaneous Electrode System

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

06

What researchers measure

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 year

07

Study locations

2 of 2 sites recruiting
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Sarasota Memorial Hospital · Sarasota, United StatesContact •••7600→•••2225Contact r•••@smh.com→R•••@smh.com
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Sarasota Memorial Hospital · Sarasota, United StatesContact •••7600→•••2225Contact r•••@smh.com→R•••@smh.com
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07218315
Responsible party
Sponsor
First posted
Oct 20, 2025
Start date
Feb 11, 2026
Primary completion
Jan 31, 2029 (estimated)
Completion
Jan 31, 2031 (estimated)
Last update
Nov 9, 2026

Study contacts

Victoria E Banuchi, MPH
Contact
vebanuchi@mdanderson.org
713-563-7600 ext. 3
Victoria E Banuchi, MPH
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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