Nanosecond Pulsed Field Ablation in the Management of Ben... | NCT07226804

Studies
Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules

NCT07226804

Sponsor

M.D. Anderson Cancer Center

Status

Recruiting

Last Update Posted

Jun 1, 2026Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Thyroid Nodules
Pulsed Field Ablation

Interventions

Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2025-08362	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 14, 2025Actual

Primary Completion Date

Aug 31, 2028Estimated

Completion Date

Aug 31, 2030Estimated

First Submitted Date

Nov 7, 2025

First Submission Date that Met QC Criteria

Nov 7, 2025

First Posted Date

Nov 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2026

Last Update Posted Date

Jun 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	patient-reported outcomes questionnaire

Measure	Description	Time Frame
Quality-of-life Questionnaire		Through study completion; an average of 1 year

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MD Anderson Cancer Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Victoria E Banuchi, MD	Contact	346-217-8668		vebanuchi@mdanderson.org

Overall Officials

Name	Affiliation	Role
Victoria E Banuchi, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MD Anderson Cancer Center	Recruiting	Houston	Texas	77030	United States

Label	URL
MD Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D016606	Thyroid Nodule

Ancestor Terms

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided