Recruiting

Radiofrequency Ablation

Sponsor:

Northwell Health

Code:

NCT05903196

Conditions

Thyroid Nodule

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Mygen V-1000 RF system

Study Details

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

Study ID

NCT05903196

Start date

Mar 12, 2024

Status verified date

Sep, 2025

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Interventions

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

Primary outcome measure

  • Number of participants with treatment-related changes in thyroid nodule volumes [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Karina Ziskovich, BBA

212-434-3715kziskovich@northwell.edu

Jose Sanchez, MD

212-434-4972jsanchez17@northwell.edu

Locations

Northwell Health Physician Partners

Recruiting

New York, New York, United States, 10022

Contacts

Karina Ziskovich, BBA

212-434-3715kziskovich@northwell.edu

Jose Sanchez Escobar, MD

212-434-4972jsanchez17@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-09-23.