Status:
ACTIVE_NOT_RECRUITING
Cryoablation of Benign Thyroid Nodules: a Pilot Study
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Benign Thyroid Nodule
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 functi...
Detailed Description
Palpable nodular thyroid disease is common in up to 6.4% of the population, and it becomes more common when the thyroid is examined by ultrasound. The vast majority of nodules are benign and, over tim...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Patients with solitary or dominant functioning or non-functioning thyroid nodules with two consecutive fine needle aspiration biopsy (FNAb)-proven benign in the last 12 months
- Thyroid nodules should be solid or almost solid (less than 40% of liquid component) with volume between 5 and 65 cc;
- Patients considered high surgical risk candidates or patients are eligible to surgery who are informed about the ablation therapy and prefers it instead surgery;
- Calcitonin, thyroglobulin or TSH serum levels in the normal range values
Exclusion
- Age under 18 years
- Extensive goiter
- Predominantly cystic nodule with small solid remnant (less than 10%)
- Nodule volume \> 65 cc
- TSH levels above the normal range
- Uncorrectable coagulopathy / impossibility to interrupt anticoagulants;
- Malignant or suspected malignant cytologic specimens;
- Pregnancy or breast-feeding;
- Anaplastic or poor-differentiated thyroid carcinoma;
- Partial thyroidectomy
- Asymptomatic patients
Key Trial Info
Start Date :
August 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06014229
Start Date
August 24 2023
End Date
November 1 2025
Last Update
January 8 2025
Active Locations (1)
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1
University of Sao Paulo General Hospital
São Paulo, São Paulo, Brazil