Radiofrequency Ablation Study in LatinX Patients

Study of the Use of Radiofrequency Ablation in LatinX Patients With Symptomatic Benign Thyroid Nodules

Benign thyroid nodules can still create cosmetic, compressive, or hormonal issues for patients. In the past, surgery was typically used to treat thyroid nodules causing the above issues through partial or complete thyroidectomy. More recently, minimally-invasive techniques have been developed to treat these issues. This study is investigating the use of one of these techniques, radiofrequency ablation, in Latinx patients with benign symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery and can be done outside an operating room. The study hypothesis is that the use of RFA is an effective and safe therapeutic option for LatinX patients with a symptomatic benign nodule wishing to avoid surgery.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Nodule
• Intervention / Treatment: Device: Mygen V-1000 RF system

Detailed Description

Thyroid nodules can create issues for individuals such as affecting the level of their thyroid hormones, causing an unwanted physical appearance, or pressing on other important structures in the neck (for example, trachea and esophagus). In the past, surgery was typically used to treat thyroid nodules causing the above issues, either taking out some or all of the thyroid. More recently, new techniques that do not require surgery have been developed to treat these issues. This study is investigating the use of one of these newer techniques, called radiofrequency ablation in Latinx patients with non-cancerous symptomatic thyroid nodules. This procedure is of interest because it avoids the risks of surgery (like bleeding, infection, scars) and can be done in a clinic setting. The theory is that this procedure will be a safe and effective alternative to surgery for non-cancerous thyroid nodules that are causing symptoms in Latinx patients, which is a population in which this treatment has not yet been studied. Patients who decide to enroll in the study will be required to fill out questionnaires, have blood tests, have ultrasounds of the thyroid, and undergo the radiofrequency ablation minimally-invasive treatment instead of surgery. Patients will be evaluated at 1 month, 3 months, 6 months, 12 months, and 18 months after the procedure to assess for effectiveness of the procedure and any side effects.

Most evidence supporting RFA of thyroid nodules comes from international cohorts. In a recent meta-analysis, RFA accomplished volume reduction ranging from 68 to 87% in over 1100 treated nodules. This reduction was sustained for up to 5 years. In terms of its safety, a recent systematic review of 2700 nodules showed only 41 major complications and 48 minor complications from RFA. Of note, most complications were transient, only 4 patients developed permanent voice changes, while 1 required rescue lobectomy after a nodule ruptured. Published data in the United States also showed RFA to be an effective and safe strategy. However, of the 47 studied patients, none were LatinX. Furthermore, lack of coverage by insurance companies means this procedure is typically only available as an out-of-pocket expense and is therefore out of reach for underserved patients. Data to establish the safety/feasibility of this novel intervention is needed for the LatinX population.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karina Ziskovich, BBA; Phone Number: 212-434-3715; Email: kziskovich@northwell.edu
• Study Contact Backup: Name: Jose Sanchez, MD; Phone Number: 212-434-4972; Email: jsanchez17@northwell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Recruiting
      • Northwell Health Physician Partners
      • Contact: Karina Ziskovich, BBA; Phone Number: 212-434-3715; Email: kziskovich@northwell.edu
      • Contact: Jose Sanchez Escobar, MD; Phone Number: 212-434-4972; Email: jsanchez17@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject capable of giving informed consent
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Subjects over 18 years of age
• Subject who self-identifies as LatinX
• Subjects who have a benign, symptomatic thyroid nodule
• Subjects whose nodule has well-defined margin on ultrasound and is surrounded by at least 2mm of normal thyroid parenchyma in all directions

Exclusion Criteria:

• Patients who are pregnant, trying to become pregnant, or breastfeeding
• Patient who have a cardiac pacemaker,defibrillator , or other electromedical equipment
• Patients who have a nodule that is malignant or not predominantly solid (must be >50% solid by ultrasound)
• Patients who cannot give consent
• Patients on anticoagulation or dual antiplatelet therapy
• Patients with acute illness
• People with BP > 140/90 prior to the scheduled procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mygen V-1000 RF system; The Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation & ablation of vessel, tissue & bone	Device: Mygen V-1000 RF system; The Mygen V-1000, a microprocessor-based generator of RF Medical Co., Ltd., provides up to 140 watts of radio-frequency (RF) energy to be used for coagulation & ablation of vessel, tissue & bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related changes in thyroid nodule volumes	To study the change in nodule volume	2 years

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Daniel Kuriloff, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

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
• Other Study ID Numbers: 22-0711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No