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Cryoablation of Benign Thyroid Nodules: a Pilot Study
Sponsor: University of Sao Paulo General Hospital
Summary
This study will evaluate the clinical response and safety of ultrasound guided percutaneous cryoablation in the treatment of benign thyroid nodules as an alternative to the surgery. Ablation of functioning or non-functioning benign thyroid nodules with cryoablation will be directed to patients with symptomatic benign thyroid lesions (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component; patients must present with serum free thyroxine (T4) and thyroid stimulating hormone (TSH) between the normal range values, with no signs of thyroiditis by serum antibodies over 100% of the standard values; calcitonin levels in the normal range values. Cryoablation will be directed to patients in a non-randomized fashion. Clinical, laboratorial and imaging monitoring will be performed in 12 months, including contrast-enhanced ultrasound when indicated, by 1, 3, 6 and 12 months.
Official title: Thermal Ablation of Benign Thyroid Nodules with Cryoablation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2023-08-24
Completion Date
2025-11-01
Last Updated
2025-01-08
Healthy Volunteers
No
Conditions
Interventions
cryoablation
Single session with an argon-based cryoablation device; an specific applicator will be used for the treatments; gas release 100% for cryoablation; local anesthesia or moderate sedation or general anesthesia at discretion of the anesthesiology / interventional radiology team; benign thyroid nodules (two benign cytological examinations) measuring between 5 and 65 mL of volume and less than 40% of cystic component;
Locations (1)
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil