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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT07168395
Eligibility Criteria:
Inclusion Criteria:
1. Age \> 18 years
2. Patients with compensated cirrhosis with a higher risk of decompensation based on AASLD 2023 Practice Guidance (Kaplan et al) - no ascites with endoscopic visualization of varices
3. Confirmed diagnosis of gastric varices either through CT, MRI, or Endoscopy.
4. No imaging (LIRAD4 or 5) or tumor marker (AFP) evidence of HCC or other malignancy
5. MELD \< 20
6. First de novo RTO procedure
7. Taking NSBB
8. Patent internal jugular or right common femoral vein
9. Willing to provide the hepatology service information for F/U
10. No known diagnosis of hypercoagulopathy
11. Patent portal vein or portal vein cavernous transformation
Exclusion Criteria:
1. Age \<18 years
2. Patients with decompensated cirrhosis based on AASLD 2023 Practice Guidance (Kaplan et al)
3. Cardiac failure
4. Active variceal bleeding
5. History of gastroesophageal variceal bleeding
6. Previous TIPS, BRTO, CARTO or PARTO procedure
7. No right jugular or right common femoral venous access
8. No portal vein flow
9. Malignancy
10. Life expectancy of less than 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07168395
Study Brief:
Protocol Section:
NCT07168395