Radiofrequency Ablation for Amiodarone-induced Thyrotoxicosis

NCT03720210 | Terminated Results FDA Device

• 1 other identifier: 18-004450
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amiodarone-Induced Thyrotoxicosis

Keywords

Hyperthyroidism; RFA

Outcome Measures

Primary Outcomes (2)

• Free T4 Response Post RFA

  Thyroid tests

  3 - 6 months

• Total T3 Response Post RFA

  Thyroid tests

  3 - 6 months

Secondary Outcomes (2)

• Pain Related to RFA Procedure

  1 - 2 months

• Thyroid-stimulating Hormone (TSH) Response Post RFA

  3 - 6 months

Study Arms (1)

RFA group

EXPERIMENTAL

RFA

Device: RFA

Interventions

RFA DEVICE

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

RFA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Limitations and Caveats

Lack of interested \& suitable candidates. The one subject enrolled was lost to follow up.

Results Point of Contact

• Title: Marius N. Stan, M.D.
• Organization: Mayo Clinic

Stan.Marius@mayo.edu

507-266-3769

Study Officials

• Marius N Stan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label single interventional series

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 25, 2018
• Study Start: November 19, 2018
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: October 11, 2021
• Results First Posted: October 11, 2021

Record last verified: 2021-09

Locations

US (1)