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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT03147768
Eligibility Criteria:
Inclusion Criteria:
Eligible participants will be 18 years and older of both genders.
1. T1a (≤ 4 cm, as measured by the maximal dimension by CT or MRI). Final determination of disease stage is made during the operation by the investigator. All resectable cystic, benign, primary or secondary malignant tumors.
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. PTT not \>1.5 times control (except for therapeutically; anticoagulated nonrelated medical conditions \[e.g., atrial fibrillation\]);
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 (\> 180 systolic and \>110 diastolic)
3. Uncorrectable coagulopathies (on Plavix, Aspirin or Lovanox)
4. Pregnancy
5. Females who are breast feeding who do not switch the infant to formula prior to surgery
6. Active urinary tract infection
7. T1b (\>4 cm) lesion and above
8. Systemic or local infection.
9. Subject has known allergy or intolerance to iodine or human serum albumin.
10. Recent febrile illness that precludes or delays participation preoperatively.
11. Treatment with another investigational drug or other intervention during the study and follow-up period.
12. Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03147768
Study Brief:
Protocol Section:
NCT03147768