Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules

NCT07226804 — Recruiting, 30 participants, M.D. Anderson Cancer Center

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RegistryNCT07226804
StatusRecruiting
Study typeObservational
Enrollment30 (Estimated)
SponsorM.D. Anderson Cancer Center (Other)
ConditionsThyroid Nodules, Pulsed Field Ablation
InterventionsQuestionnaire (Other)
Datesstart 2025-11-14, primary completion 2028-08-31 (estimated), completion 2030-08-31 (estimated), first posted 2025-11-10, last updated 2026-06-01
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Thyroid Nodules All trials for Pulsed Field Ablation All trials of Questionnaire

-Summary

To observe the outcomes of nsPFA therapy to treat benign thyroid nodules.

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+Detailed description

Primary Objectives

• To evaluate the thyroid nodule volume changes over time in participants undergoing nsPFA as part of routine clinical care

Secondary Objectives

* To determine changes in health-related quality of life changes following ultrasound-guided nsPFA
* To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA.
* To assess the incidence and nature of complications following ultrasound-guided nsPFA, categorized into Minor and Major complications.

+Arms and interventions

  • Questionnaire (Other): patient-reported outcomes questionnaire

+Outcome measures

Primary outcomes

  • Quality-of-life Questionnaire [Through study completion; an average of 1 year]

+Eligibility

Sex: All, ages: 18 Years to any

Eligibility Criteria

* Scheduled to undergo ultrasound guided nsPFA as standard of care
* Age 18 to 80 years.
* Capable of providing independent consent.
* Presence of biopsy-confirmed benign thyroid nodule , defined as one of the following:

  * Benign FNA X 2 or
  * Benign US guided FNA X 1 + benign thyroid nodule ultrasound appearance (TI-RADS 2) or
  * Benign FNA X 1 and radiographic/laboratory evidence of functional nature
* Nodule measuring >2cm in greatest dimension
* Presence of compressive symptoms reasonably attributable to thyroid nodule (i.e. pressure sensation, dysphagia, dysphonia, respiratory distress)
* No abnormal cervical lymph nodes during screening visit .

Exclusion Criteria

* Age <18
* Patients considered unsuitable for nsPFA by the treating physician

+Locations (1)

FacilityCityCountryStatus
MD Anderson Cancer CenterHouston, TexasUnited StatesRecruiting

+Investigators