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NCT Number: NCT05189314

RFA of Benign Thyroid Nodules: Clinical Outcomes and Quality of Life Study

The purpose of this observational research is to evaluate and compare clinical outcomes after treatment for symptomatic benign multinodular goiter (MNG) patients. This is a data collection study in which we ask participants to give access to information generated before and after treatment of their condition.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University

New York, 10032, United States

Location status: Recruiting

Location contact

Jennifer H Kuo, MD MS

CONTACT

[email protected]

212-305-6969

About this study

Benign multinodular goiter (MNG) refers to an enlarged thyroid gland with nodules within it, frequently owing to iodine deficiency. It is the most common endocrine disorder worldwide.

Significant growths of nodules can cause symptomatic compressive symptoms such as dysphagia, dyspnea, or vascular compression of the neck vessels. On occasion, these nodules can develop autonomy and secrete excess thyroid hormone (toxic multinodular goiter). Surgical resection has been the preferred treatment option for symptomatic multinodular goiters and addresses both compressive symptoms as well as hyperthyroidism, but is associated with small, but not negligible risk of nerve injury, hypoparathyroidism, and may confer a risk of hypothyroidism and dependence on thyroid hormone supplementation.

Thermoablative methods that induce local thermodestruction leading to nodule shrinkage and improvement in local symptoms and hyperthyroidism have recently emerged as a possible alternative treatment approach for MNG. Monopolar radiofrequency ablation (RFA) is presently the best documented thermoablative technique. Although RFA of thyroid nodules specifically, is still considered investigational in the United States, RFA of thyroid nodules has been used by several centers globally (mainly in South Korea, Italy, China, and Austria) since 2006 with excellent clinical outcomes. In addition, RFA of other solid tumors is a commonly performed procedure in the United states and all RFA devices, including the device that we will use for the clinical care of these patients, are cleared by the FDA (New devices/technology to the market are approved, but devices that have a predicate device/technology that are already on the market only need to be cleared). In response to its increasing popularity, the Korean Society of Thyroid Radiology commissioned a Task Force to develop recommendations for the optimal use of radiofrequency ablation for thyroid tumors in 2012, and these recommendations were recently revised in 2017 and the American Association of Clinical Endocrinologists recently recommended that ultrasound guided thermal ablation treatments be considered for solid or mixed symptomatic benign thyroid nodules.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients >/=18 years old with benign thyroid nodules

Exclusion criteria

  • cardiac arrhythmia
  • pregnancy

Treatment and study plan

Thyroidectomy

Procedure

Surgical Resection of thyroid nodules

Radiofrequency Ablation

Device

Radiofrequency Ablation of thyroid nodules

Primary outcomes

  1. Percent Volume Change of Nodules

    Time frame: 6 months and 12 months

    Percent Volume Change of Nodules: ((Volume (baseline) - Volume (*m*))/Volume(baseline))*100

  2. Change in Thyroid Stimulating Hormone (TSH)

    Time frame: 6 months and 12 months

    Change in serum TSH

  3. ThyPRO 39 Survey Score

    Time frame: 12 months

    The Thypro 39 is a survey assessing quality of life in patients with thyroid disease. Scores range from 0-100 with a higher score indicating a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer H Kuo, MD MS

CONTACT

[email protected]

212-305-6969

Vilma Rosario

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Clinical Outcomes and Quality of Life Measures After Surgical Resection and Radiofrequency Ablation of Benign Thyroid Nodules

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Jan 12, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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