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 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT06868992
Eligibility Criteria:
* Inclusion Criteria \* :
* Female or male adult patients
* Patient who has benefited from a pluridisciplinary evaluation (medical, surgical, psychiatric), with a favorable opinion for a sleeve gastrectomy or a gastric bypass.
* Patient with an indication Indication for intraoperative liver biopsy due to suspected MASH
* Patient who agrees to be included in the study and who signs the informed consent form,
* Patient affiliated to a healthcare insurance plan.
* Exclusion Criteria \* :
* Patient presenting Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
* Patient presenting previous or current infection with Hepatitis C
* Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
* Patient presenting Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
* Patient presenting Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
* Patient presenting Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
* Patient presenting Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
* Patient presenting Drug-induced liver disease as defined on the basis of typical exposure and history.
* Patient presenting Bile duct obstruction as shown by imaging studies.
* History of ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, methotrexate, amiodarone or tetracycline in the previous 6 months.
* Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices
* Consommation régulière et/ou excessive d'alcool (plus de 30g/j pour les hommes et plus de 15 g/j pour les femmes) sur une période de plus de 2 ans au cours des 10 dernières années.
* History of known HIV infection
* History of type 1 diabetes
* Pregnant women or breastfeeding mothers\*.
* Minor patient
* Patient deprived of liberty,
* Patients under psychiatric care
* Patients admitted to a health or social care establishment for purposes other than research
* Mentally unbalanced patients, under supervision or guardianship,
* Patients not affiliated to a social security scheme or benefiting from a similar scheme
* Patient who does not understand French/ is unable to give consent,
* Patient already included in a trial who may interfere with the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06868992
Study Brief:
Protocol Section:
NCT06868992