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Very low enrollment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA group | Experimental | RFA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFA | Device | Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Free T4 Response Post RFA | Thyroid tests | 3 - 6 months |
| Total T3 Response Post RFA | Thyroid tests | 3 - 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Related to RFA Procedure | McGill Pain Questionnaire | 1 - 2 months |
| Thyroid-stimulating Hormone (TSH) Response Post RFA | Thyroid tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marius N Stan, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | RFA Group | RFA (Radiofrequency Ablation) RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RFA Group | RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Free T4 Response Post RFA | Thyroid tests | The one subject enrolled did not return for follow up. Data not collected or analyzed. | Posted | 3 - 6 months |
|
|
Adverse events were collected from RFA procedure to 72 hours post RFA procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RFA Group | RFA RFA: Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis |
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Lack of interested & suitable candidates. The one subject enrolled was lost to follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marius N. Stan, M.D. | Mayo Clinic | 507-266-3769 | Stan.Marius@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2018 | Sep 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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Open label single interventional series
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| 3 - 6 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Primary | Total T3 Response Post RFA | Thyroid tests | The one subject enrolled did not return for follow up. Data not collected or analyzed. | Posted | 3 - 6 months |
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| Secondary | Pain Related to RFA Procedure | McGill Pain Questionnaire | The one subject enrolled did not return for follow up. Data not collected or analyzed. | Posted | 1 - 2 months |
|
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| Secondary | Thyroid-stimulating Hormone (TSH) Response Post RFA | Thyroid tests | The one subject enrolled did not return for follow up. Data not collected or analyzed. | Posted | 3 - 6 months |
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| 0 |
| 1 |
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