What side effects are associated with this type of intervention?

Radiofrequency Ablation (RFA) for thyroid nodules commonly results in side effects such as pain at the treatment site, swelling, and potential damage to surrounding structures like nerves or blood vessels. Other possible side effects include infection, bleeding, and voice changes due to nerve damage. These side effects are typically mild and temporary but can occasionally be more severe.

What prior FDA approvals exist?

The FDA has approved several treatments for thyroid nodules, including minimally invasive techniques like Radiofrequency Ablation (RFA). RFA uses heat generated by radio waves to destroy thyroid tissue, effectively reducing nodule size and alleviating symptoms. This method offers an alternative to traditional surgical approaches, providing a less invasive option for patients. While specific FDA approvals for RFA in thyroid nodules are not detailed, the technique is widely recognized and utilized in clinical practice for its efficacy and safety.

What other types of research exist?

Promising, novel alternatives to Radiofrequency Ablation (RFA) for thyroid nodule patients include High-Intensity Focused Ultrasound (HIFU) and Photodynamic Therapy (PDT). HIFU uses sonic waves to create thermal energy that destroys target tissue, while PDT involves the use of light-sensitive drugs and light to destroy abnormal cells. Both methods are minimally invasive and have shown potential in clinical studies, though more long-term data is needed to fully establish their efficacy.

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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

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:

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I am unable to give consent for medical procedures.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

0 / 4Eligibility criteria met

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.