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RecruitingNCT05189314Updated May 29, 2026

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

An observational study in Thyroid Nodules, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Columbia University · Observational

From the registry’s dates

  • Started Aug 2019; still recruiting 7 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Thyroid Nodules

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Keywords

  • Radiofrequency Ablation
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In context

Thyroid Nodule

207 studies on the registry are indexed under Thyroid Nodule; 64 are open to participants now.

This study's planned enrollment of 100 is below the median of 161 across 82 observational studies indexed under Thyroid Nodule.

Browse Thyroid Nodule studies →

Lead sponsor

Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.

Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patients (>/=18 years) with benign, non-functional benign thyroid nodules

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • cardiac arrhythmia
  • pregnancy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Thyroidectomy

    Patients with benign thyroid nodules who undergo surgical resection

    Procedure: Thyroidectomy

  • RFA

    Patients with benign thyroid nodules who undergo radiofrequency ablation

    Device: Radiofrequency Ablation

Interventions

  • ProcedureThyroidectomy

    Surgical Resection of thyroid nodules

  • DeviceRadiofrequency Ablation

    Radiofrequency Ablation of thyroid nodules

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What researchers measure

Primary outcomes

  1. Percent Volume Change of Nodules

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

    Time frame: 6 months and 12 months

  2. Change in Thyroid Stimulating Hormone (TSH)

    Change in serum TSH

    Time frame: 6 months and 12 months

  3. ThyPRO 39 Survey Score

    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.

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Durante C, Costante G, Lucisano G, Bruno R, Meringolo D, Paciaroni A, Puxeddu E, Torlontano M, Tumino S, Attard M, Lamartina L, Nicolucci A, Filetti S. The natural history of benign thyroid nodules. JAMA. 2015 Mar 3;313(9):926-35. doi: 10.1001/jama.2015.0956. PubMed 25734734 ↗
  • de Rienzo-Madero B, Sabra JP, Gand E, Donatini G, Kraimps JL. Unilateral benign multinodular versus solitary goiter: Long-term contralateral reoperation rates after lobectomy. Surgery. 2019 Jan;165(1):75-79. doi: 10.1016/j.surg.2018.04.074. Epub 2018 Nov 8. PubMed 30415868 ↗
  • Kim YS, Rhim H, Tae K, Park DW, Kim ST. Radiofrequency ablation of benign cold thyroid nodules: initial clinical experience. Thyroid. 2006 Apr;16(4):361-7. doi: 10.1089/thy.2006.16.361. PubMed 16646682 ↗
  • Na DG, Lee JH, Jung SL, Kim JH, Sung JY, Shin JH, Kim EK, Lee JH, Kim DW, Park JS, Kim KS, Baek SM, Lee Y, Chong S, Sim JS, Huh JY, Bae JI, Kim KT, Han SY, Bae MY, Kim YS, Baek JH; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations. Korean J Radiol. 2012 Mar-Apr;13(2):117-25. doi: 10.3348/kjr.2012.13.2.117. Epub 2012 Mar 7. PubMed 22438678 ↗
  • Kim JH, Baek JH, Lim HK, Ahn HS, Baek SM, Choi YJ, Choi YJ, Chung SR, Ha EJ, Hahn SY, Jung SL, Kim DS, Kim SJ, Kim YK, Lee CY, Lee JH, Lee KH, Lee YH, Park JS, Park H, Shin JH, Suh CH, Sung JY, Sim JS, Youn I, Choi M, Na DG; Guideline Committee for the Korean Society of Thyroid Radiology (KSThR) and Korean Society of Radiology. 2017 Thyroid Radiofrequency Ablation Guideline: Korean Society of Thyroid Radiology. Korean J Radiol. 2018 Jul-Aug;19(4):632-655. doi: 10.3348/kjr.2018.19.4.632. Epub 2018 Jun 14. PubMed 29962870 ↗
  • Gharib H, Papini E, Garber JR, Duick DS, Harrell RM, Hegedus L, Paschke R, Valcavi R, Vitti P; AACE/ACE/AME Task Force on Thyroid Nodules. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS, AMERICAN COLLEGE OF ENDOCRINOLOGY, AND ASSOCIAZIONE MEDICI ENDOCRINOLOGI MEDICAL GUIDELINES FOR CLINICAL PRACTICE FOR THE DIAGNOSIS AND MANAGEMENT OF THYROID NODULES--2016 UPDATE. Endocr Pract. 2016 May;22(5):622-39. doi: 10.4158/EP161208.GL. PubMed 27167915 ↗
  • Jeong WK, Baek JH, Rhim H, Kim YS, Kwak MS, Jeong HJ, Lee D. Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Eur Radiol. 2008 Jun;18(6):1244-50. doi: 10.1007/s00330-008-0880-6. Epub 2008 Feb 20. PubMed 18286289 ↗
  • Baek JH, Kim YS, Lee D, Huh JY, Lee JH. Benign predominantly solid thyroid nodules: prospective study of efficacy of sonographically guided radiofrequency ablation versus control condition. AJR Am J Roentgenol. 2010 Apr;194(4):1137-42. doi: 10.2214/AJR.09.3372. PubMed 20308523 ↗
  • Watt T, Barbesino G, Bjorner JB, Bonnema SJ, Bukvic B, Drummond R, Groenvold M, Hegedus L, Kantzer V, Lasch KE, Marcocci C, Mishra A, Netea-Maier R, Ekker M, Paunovic I, Quinn TJ, Rasmussen AK, Russell A, Sabaretnam M, Smit J, Torring O, Zivaljevic V, Feldt-Rasmussen U. Cross-cultural validity of the thyroid-specific quality-of-life patient-reported outcome measure, ThyPRO. Qual Life Res. 2015 Mar;24(3):769-80. doi: 10.1007/s11136-014-0798-1. Epub 2014 Sep 7. PubMed 25194574 ↗
  • Dobnig H, Amrein K. Monopolar Radiofrequency Ablation of Thyroid Nodules: A Prospective Austrian Single-Center Study. Thyroid. 2018 Apr;28(4):472-480. doi: 10.1089/thy.2017.0547. Epub 2018 Mar 20. PubMed 29490593 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05189314
Responsible party
Jennifer Kuo (Associate Professor, Columbia University) — Principal investigator
First posted
Jan 12, 2022
Start date
Aug 30, 2019
Primary completion
Aug 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
May 29, 2026

Study contacts

Jennifer H Kuo, MD MS
Contact
jhk2029@cumc.columbia.edu
212-305-6969
Vilma Rosario
Contact
vr2222@cumc.columbia.edu
Jennifer H Kuo, MD MS
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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