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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT04281303
Eligibility Criteria:
Inclusion Criteria:
* 1\) Subjects between the ages of 18 and 65 (inclusive) at the time of the first selection visit 2) They must provide a signed written informed consent and agree to comply with the study protocol.
3\) Subjects with a BMI greater than 30 kg/m2 whether or not associated with metabolic risk factors (MD, hypertension, dyslipemia).
4\) Confirmed diagnosis of non-alcoholic steatohepatitis with a degree of fibrosis 4 according to the NASH CRN staging system in a liver biopsy obtained in the 12 months prior to the endoscopic procedure or during the screening period.
5\) Absence of other causes of chronic liver disease (alcoholic, viral, autoimmune, cholestatic disease, Wilson's disease, α1AT deficit, hemochromatosis)
Exclusion Criteria:
1. Current or past history of any liver decompensation event (ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome, hepatopulmonary syndrome).
2. Child-Pugh Scale ≥ 7 points.
3. MELD scale \> 12
4. Documented presence of varicose veins based on a previous endoscopy performed in the 6 months prior to the intervention.
5. Documented presence of collateral circulation based on an echoendoscopy and/or thoraco-abdominal CT with 3D reconstruction performed in the selection period.
6. Presence of a hepatic venous pressure gradient (HVPG) ≥ 10 mmHg in a hemodynamic study performed in the 4 months prior to surgery or in the selection period.
7. Known heart failure (Grade I-IV of the New York Heart Association classification).
8. History of bariatric surgery
9. Patients with a history of clinically significant cardiovascular events in the 6 months prior to the endoscopic procedure, such as an acute cardiovascular event, stroke, transient ischemic attack, or coronary heart disease (angina, myocardial infarction, revascularization procedures).
10. Weight loss of more than 5 % in the 6 months prior to the operation.
11. Recent or current history of significant consumption of alcoholic beverages (\< 5 years) For men, significant consumption is usually defined as more than 30 g of pure alcohol per day. For women, it is normally defined as more than 20 g of pure alcohol per day.
12. Hepatocarcinoma. (13) Portal thrombosis.
14\) Pregnancy. 15) Refusal to give informed consent. 16) Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
17\) Indications of any other untreated, unstable or clinically significant immunological, endocrine, haematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
18\) Mental instability or incompetence such that the validity of the informed consent or the ability to comply with the study is uncertain.
19\) Positive antibodies to human immunodeficiency virus. 20) Data on decompensated liver disease:
1. Aspartate aminotransferase (AST) and/or ALT \> 10 x upper limit of normality (LSN)
2. Total bilirubin \> 2 mg/dL
3. International Normalized Ratio (INR) \> 1,4
4. Platelet count ≤ 100 000/mm3.
5. Albumin \< 3.5 g/dL. 21) Serum creatinine levels \> 135 μmol/l (\> 1.53 mg/dl) in men and \> 110 μmol/l (\> 1.24 mg/dl) in women 22) Significant renal disease, including nephrotic syndrome, chronic renal disease (patients with markers of liver injury or estimated glomerular filtration rate \[eGFR\] of less than 60 ml/min/1.73 m2). If an abnormal value is obtained at the first screening visit, eGFR measurement may be repeated before randomisation within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the intended randomisation. Repeated abnormal eGFR (less than 60 ml/min/1,73 m2 ) leads to exclusion from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04281303
Study Brief:
Protocol Section:
NCT04281303