Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT04782856
Eligibility Criteria:
Inclusion Criteria:
1. Clinical indication for total thyroidectomy
2. TSH at screening \>0.045\<4.5mlU/m
3. Adult men and women Age ≥18-89 years of age
4. Euthyroid patients with clinical indication for total thyroidectomy
5. Indication to total thyroidectomy for benign goiter or thyroid cancer not requiring suppressive thyroid hormone therapy
Exclusion Criteria:
1. Weight \<50 or \>150 Kg
2. Graves' disease
3. Use of thyroid hormone therapy or thyroid supplements (at screening) except for multinodular goiter
4. Indication for thyroid hormone suppressive therapy following surgery
5. Uncontrolled arterial hypertension stage 2 or greater (\>140/90 mm Hg at screening) while on medication (patients with hypertension controlled by therapy will be allowed to participate).
6. Uncontrolled diabetes (HbA1c \> 8.% at screening or Fructosamine \> 325 mmol/L)
7. History of cardiovascular disease, congestive heart failure or unstable coronary artery disease (angina, coronary event, or revascularization within 6 months); atrial fibrillation; or ventricular arrhythmia,
8. History of major depression or psychosis
9. Patients who are Pregnant, breastfeeding planned pregnancy within six months from the thyroidectomy
10. Any conditions that in the opinion of the PI may impede the successful completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT04782856
Study Brief:
Protocol Section:
NCT04782856