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TerminatedNCT03720210Updated Oct 11, 2021Results posted

Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

An interventional study of RFA in Amiodarone-Induced Thyrotoxicosis, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-11.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment

Why this study was terminated
Very low enrollment
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Amiodarone-Induced Thyrotoxicosis

Keywords

  • Hyperthyroidism
  • RFA
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    RFA group

    RFA

    Device: RFA

Interventions

  • DeviceRFA

    Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis

06

What researchers measure

Primary outcomes

  1. Free T4 Response Post RFA

    Thyroid tests

    Time frame: 3 - 6 months

  2. Total T3 Response Post RFA

    Thyroid tests

    Time frame: 3 - 6 months

Secondary outcomes

  1. Pain Related to RFA Procedure

    McGill Pain Questionnaire

    Time frame: 1 - 2 months

  2. Thyroid-stimulating Hormone (TSH) Response Post RFA

    Thyroid tests

    Time frame: 3 - 6 months

07

Results

Posted Oct 11, 2021
Limitations and caveats
Lack of interested \& suitable candidates. The one subject enrolled was lost to follow up.

Participant flow

Participant flow — Overall Study
MilestoneRFA Group
Started1
Completed0
Not completed1
Withdrew: Lost to follow-up1

Outcome measures

PrimaryFree T4 Response Post RFA

Thyroid tests

Time frame:
3 - 6 months

No measurements were reported for this outcome.

PrimaryTotal T3 Response Post RFA

Thyroid tests

Time frame:
3 - 6 months

No measurements were reported for this outcome.

SecondaryPain Related to RFA Procedure

McGill Pain Questionnaire

Time frame:
1 - 2 months

No measurements were reported for this outcome.

SecondaryThyroid-stimulating Hormone (TSH) Response Post RFA

Thyroid tests

Time frame:
3 - 6 months

No measurements were reported for this outcome.

Adverse events

Collected over Adverse events were collected from RFA procedure to 72 hours post RFA procedure.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RFA Group0/1 (0%)0/1 (0%)0/1 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)RFA Group
Age 311
Sex: Female, Male
Sex: Female, Male(Participants)RFA Group
Female0
Male1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)RFA Group
American Indian or Alaska Native1
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)RFA Group
United States1
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Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 29, 2018

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2021, 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
NCT03720210
Lead sponsor
Mayo Clinic
Responsible party
Marius Stan (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Oct 25, 2018
Start date
Nov 19, 2018
Primary completion
Dec 7, 2020
Completion
Dec 7, 2020
Results posted
Oct 11, 2021
Last update
Oct 11, 2021

Study contacts

Marius N Stan, MD
principal investigator · Mayo Clinic

Oversight

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

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This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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