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Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720210
Recruitment Status : Terminated (Very low enrollment)
First Posted : October 25, 2018
Results First Posted : October 11, 2021
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic

Brief Summary:
Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.

Condition or disease Intervention/treatment Phase
Amiodarone-Induced Thyrotoxicosis Device: RFA Not Applicable

Detailed Description:

Investigators plan to identify patients with amiodarone-induced thyrotoxicosis (AIT) that failed to respond to medical therapy or have developed side effects from medical therapy or are considered high risk for such therapy.

These patients will be offered the option to undergo radiofrequency ablation (RFA) of a portion of the thyroid gland in order to decrease thyroid hormone production and/or to inactive the existing thyroid hormone store before their leakage into the circulation.

Investigators will follow these patients to assess their clinical response as well as their thyroid values. The safety of the procedure will also be assessed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label single interventional series
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study for Treatment of Amiodarone-Induced Thyroiditis With Radiofrequency Ablation
Actual Study Start Date : November 19, 2018
Actual Primary Completion Date : December 7, 2020
Actual Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Amiodarone

Arm Intervention/treatment
Experimental: RFA group
RFA
Device: RFA
Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis




Primary Outcome Measures :
  1. Free T4 Response Post RFA [ Time Frame: 3 - 6 months ]
    Thyroid tests

  2. Total T3 Response Post RFA [ Time Frame: 3 - 6 months ]
    Thyroid tests


Secondary Outcome Measures :
  1. Pain Related to RFA Procedure [ Time Frame: 1 - 2 months ]
    McGill Pain Questionnaire

  2. Thyroid-stimulating Hormone (TSH) Response Post RFA [ Time Frame: 3 - 6 months ]
    Thyroid tests



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are adults
  • Have overt thyrotoxicosis (within 2 weeks prior to enrollment)
  • Are receiving medical therapy for AIT
  • Are able to understand the study procedures and to comply with them for the entire length of the study
  • Have not normalized their thyroid levels after one month of standard therapy or
  • Have persistent and clinically significant thyrotoxicosis (less than 25% decrease in T4 value or patients requiring hospitalization with Congestive heart failure (CHF), tachyarrhythmias, hemodynamic instability or similar co-morbidities) after 2 weeks of standard therapy where additional medical therapy is deemed unlikely to be beneficial or with high risk of side-effects (e.g. hepatotoxicity of antithyroid medications, agranulocytosis of potassium perchlorate or ATD or fluid retention associated with steroids).

Exclusion Criteria:

  • Pregnancy
  • Patients with prior neck surgery or neck radiation
  • Patients with neck anatomy that precludes easy access by RFA to the entirety of thyroid parenchyma
  • Patients on anticoagulation therapy
  • Patients with comorbidities deemed too high of a risk for general anesthesia
  • Treatment with another investigational drug or intervention (within 6 weeks of planned RFA).
  • Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720210


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Marius N Stan, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Marius Stan, Mayo Clinic:
Additional Information:
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Responsible Party: Marius Stan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03720210    
Other Study ID Numbers: 18-004450
First Posted: October 25, 2018    Key Record Dates
Results First Posted: October 11, 2021
Last Update Posted: October 11, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Marius Stan, Mayo Clinic:
Hyperthyroidism
RFA
Additional relevant MeSH terms:
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Thyrotoxicosis
Hyperthyroidism
Thyroid Diseases
Endocrine System Diseases