Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Victoria E Banuchi, MD
- Phone Number: 346-217-8668
- Email: VEBanuchi@mdanderson.org
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
-
Contact:
- Victoria E Banuchi, MD
- Phone Number: 346-217-8668
- Email: VEBanuchi@mdanderson.org
-
Principal Investigator:
- Victoria E Banuchi, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality-of-life Questionnaire
Time Frame: Through study completion; an average of 1 year
|
Through study completion; an average of 1 year
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Victoria E Banuchi, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Neoplasms by Site
- Neoplasms
- Thyroid Neoplasms
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Thyroid Diseases
- Thyroid Nodule
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
Other Study ID Numbers
- 2025-0483
- NCI-2025-08362 (Other Identifier: NCI-CTRP Clinical Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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