NCT07218315

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
58mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Jan 2031

First Submitted

Initial submission to the registry

October 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

February 11, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2031

Last Updated

April 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

October 16, 2025

Last Update Submit

April 23, 2026

Conditions

Thyroid Carcinoma

Outcome Measures

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

    Through study completion; an average of 1 year

Study Arms (1)

Treatment with nsPFA

EXPERIMENTAL

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

CellFX nsPFA Percutaneous Electrode SystemDEVICE

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

Treatment with nsPFA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Victoria E Banuchi, MPH

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria E Banuchi, MPH

CONTACT

713-563-7600vebanuchi@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2025

First Posted

October 20, 2025

Study Start

February 11, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2031

Last Updated

April 27, 2026

Record last verified: 2026-03

Locations

US(2)