NL-OMON54080
Recruiting
Phase 3
ltrasound-guided Radiofrequency Ablation versus radioactive iodine as Treatment for Hyperthyroidism caused by Solitary Autonomous Thyroid Nodules - RABITO study
Rijnstate Ziekenhuis0 sites232 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- hyperactive nodule
- Sponsor
- Rijnstate Ziekenhuis
- Enrollment
- 232
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \> 18 years
- •\- Hyperthyroidism or subclinical hyperthyroidims caused by a solitary
- •hyperactive thyroid nodule (HTN), either located in an otherwise normal thyroid
- •gland, or in a multinodular goitre (MNG)
- •\- Treatment with RAI indicated and eligible for RFA
- •\- Signed informed consent
Exclusion Criteria
- •\- Multifocal HTN
- •\- HTN \> 50 mm
- •\- Presence of a medical device susceptible to disturbances caused by RFA
- •generated currents
- •\- Patients with physical or behavioural disorders that preclude safe isolation
- •in radiation protection rooms, or safe RFA procedure under local anesthesia
- •\- Uncorrectable hemorrhagic diathesis
- •\- Pregnancy
Outcomes
Primary Outcomes
Not specified
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