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Procedure

Radiofrequency Ablation for Thyroid Nodules

N/A
Recruiting
Led By Daniel Kuriloff, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects who have a benign, symptomatic thyroid nodule
Be older than 18 years old
Must not have
Patients who cannot give consent
Patients who have a nodule that is malignant or not predominantly solid (must be >50% solid by ultrasound)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a procedure called radiofrequency ablation (RFA) for Latinx patients with non-cancerous thyroid nodules that cause symptoms. RFA uses heat from radio waves to shrink or destroy the nodules without surgery. The goal is to see if RFA is a safe and effective alternative to surgery for these patients. RFA is a minimally invasive technique that has been widely used for the management of benign thyroid nodules, with evidence supporting its safety and efficacy.

Who is the study for?
This trial is for Latinx individuals over 18 with benign, symptomatic thyroid nodules who can consent to treatment and follow study procedures. They must have a well-defined nodule on ultrasound. It's not for those on blood thinners, with acute illness, high blood pressure, cardiac devices, or pregnant/breastfeeding women.
What is being tested?
The Mygen V-1000 RF system is being tested as a minimally-invasive alternative to surgery for treating thyroid nodules in Latinx patients. The goal is to see if radiofrequency ablation (RFA) can safely resolve issues without the risks associated with traditional surgery.
What are the potential side effects?
While specific side effects are not listed here, RFA may generally include discomfort at the site of treatment, swelling, bruising or minor bleeding. Since it avoids surgery risks like anesthesia complications and significant bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a non-cancerous thyroid lump that causes symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to give consent for medical procedures.
Select...
My tumor is mostly solid and confirmed malignant.
Select...
I am currently on blood thinners or taking two types of medication to prevent blood clots.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with treatment-related changes in thyroid nodule volumes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Mygen V-1000 RF systemExperimental Treatment1 Intervention
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for thyroid nodules include surgical excision, radioactive iodine ablation, and radiofrequency ablation (RFA). Surgical excision involves removing part or all of the thyroid gland to eliminate the nodule and prevent potential malignancy. Radioactive iodine ablation uses radioactive iodine to destroy thyroid tissue, effectively reducing nodule size and thyroid hormone production. RFA, a minimally-invasive technique, uses heat generated by radio waves to destroy nodule tissue, thereby reducing its size and alleviating symptoms such as compression and cosmetic concerns. These treatments are crucial for managing symptoms, preventing complications, and addressing potential malignancy in thyroid nodule patients.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,090 Total Patients Enrolled
Daniel Kuriloff, MDPrincipal InvestigatorNorthwell Health

Media Library

Mygen V-1000 RF system (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05903196 — N/A
Thyroid Nodule Research Study Groups: Mygen V-1000 RF system
Thyroid Nodule Clinical Trial 2023: Mygen V-1000 RF system Highlights & Side Effects. Trial Name: NCT05903196 — N/A
Mygen V-1000 RF system (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05903196 — N/A
~18 spots leftby Jun 2025