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
Investigators intend to study the changes in thyroid hormone storage and production in amiodarone-induced thyrotoxicosis patients after RFA therapy.
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.
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.
Exclusion Criteria:
RFA
Device: RFA
Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
Free T4 Response Post RFA
Thyroid tests
Time frame: 3 - 6 months
Total T3 Response Post RFA
Thyroid tests
Time frame: 3 - 6 months
Pain Related to RFA Procedure
McGill Pain Questionnaire
Time frame: 1 - 2 months
Thyroid-stimulating Hormone (TSH) Response Post RFA
Thyroid tests
Time frame: 3 - 6 months
| Milestone | RFA Group |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
Thyroid tests
No measurements were reported for this outcome.
Thyroid tests
No measurements were reported for this outcome.
McGill Pain Questionnaire
No measurements were reported for this outcome.
Thyroid tests
No measurements were reported for this outcome.
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RFA Group | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Customized(Participants) | RFA Group |
|---|---|
| Age 31 | 1 |
| Sex: Female, Male(Participants) | RFA Group |
|---|---|
| Female | 0 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | RFA Group |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | RFA Group |
|---|---|
| United States | 1 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Thyrotoxicosis
Mayo Clinic