Radiofrequency Ablation Study in LatinX Patients

NCT05903196 | Recruiting DMC FDA Device

• 1 other identifier: 22-0711
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related changes in thyroid nodule volumes

  To study the change in nodule volume

  2 years

Study Arms (1)

Mygen V-1000 RF system

EXPERIMENTAL

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

Interventions

Mygen V-1000 RF system DEVICE

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

Mygen V-1000 RF system

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health Physician Partners

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule

Condition Hierarchy (Ancestors)

Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Daniel Kuriloff, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karina Ziskovich, BBA

CONTACT

212-434-3715; kziskovich@northwell.edu

Jose Sanchez, MD

CONTACT

212-434-4972; jsanchez17@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Thyroid & Parathyroid Surgery

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 15, 2023
• Study Start: March 12, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)