Radiofrequency Ablation Study in LatinX Patients

Not Applicable

Recruiting

• Conditions: Thyroid Nodule
• Interventions: Device: Mygen V-1000 RF system

• Registration Number: NCT05903196
• Lead Sponsor: Northwell Health

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.

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 Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Study Start: 2024-03-12
• Last Update Posted: 2024-03-12
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mygen V-1000 RF system	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 Measures

Name	Time	Method
Number of participants with treatment-related changes in thyroid nodule volumes	2 years	To study the change in nodule volume

Trial Locations

Locations (1)

Northwell Health Physician Partners; 🇺🇸 New York, New York, United States