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:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT02061605
Eligibility Criteria:
Inclusion Criteria:
1. T1a (\< 4 cm). All resectable benign, primary or secondary malignant tumors of one kidney. No bi-lateral disease.
2. Serum creatinine: ≤ 2.5 mg/dL
3. Glomerular filtration rate greater than ≥ 50 ml/min/m2
4. Platelet count ≥ 50,000/mm3
5. Prothrombin time \< 18 seconds
6. Partial thromboplastin time (PTT) ≤ 1.5 times control
7. Serum albumin levels \> 3g/dL (Normal range 3.5 to 5 g/dL)
Exclusion Criteria:
1. Age younger than 18 years old
2. Severe uncorrected hypertension
3. Uncorrectable coagulopathies
4. Pregnancy
5. Active urinary tract infection
6. T1b (\>4 cm) lesion and above
7. Systemic or local infection
8. Subject has known allergy or intolerance to iodine or human serum albumin
9. Recent febrile illness that precludes or delays participation pre-operatively
10. Treatment with another investigational drug or other intervention during the study and follow-up period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02061605
Study Brief:
Protocol Section:
NCT02061605