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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT05760235
Eligibility Criteria:
Inclusion Criteria:
* Adult patients (i.e., age between 18 and 70 years).
* BMI ≥ 35 kg/m²;
* Subjects with an indication to liver transplantation that are not listed because of a high BMI according to the policy of the transplant Centre (cut-off 35 kg/m2);
* Signed informed consent.
Exclusion Criteria:
* Clinically significant portal hypertension at upper endoscopy: F3 or F1/F2 with red signs oesophageal varices, gastric varices or severe hypertensive gastropathy;
* Upper gastro-intestinal bleeding (gastric or esophageal) in the previous six months;
* CHILD C class;
* Clinically or ultrasound-detected ascites in the 15 days before the procedure. Only mild ascitic effusion in the pelvis will be accepted;
* Spontaneous bacterial peritonitis in the previous 6 months;
* Hepatocellular carcinoma with extra hepatic spread;
* Previous stomach, oesophagus or duodenum surgery;
* Technical non-feasibility in the opinion of the endoscopist;
* Clinical signs of active infection;
* Unstable cardiac disease or chronic heart failure;
* Platelet count less than 70.000;
* International Normalized Ratio ≥ 1,5;
* Concomitant unstoppable anticoagulant or anti platelet therapy, except for low dose aspirin (≤ 100 mg);
* Acute liver failure;
* Easy to bleed during diagnostic endoscopy;
* Active drugs or alcohol abuse;
* Pregnancy, lactation (desire to become pregnant during study duration);
* Enrolment in other clinical studies;
* Contraindication to general anaesthesia;
* Contraindication to endoscopic procedure;
* Other conditions to exclude the subject in investigators opinion;
* Refusal to sign informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05760235
Study Brief:
Protocol Section:
NCT05760235