Phase
Condition
Liver Disorders
Liver Disease
Primary Biliary Cholangitis
Treatment
Endoscopic Sleeve Gastroplasty
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG
Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG)
Patients older than 18 years and younger than 75 years of age at the time of consent
Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
Patients willing and able to comply with study requirements for follow-up
Exclusion
Exclusion criteria:
Patients who are treated with intragastric balloons
Family history of esophageal, gastric, or duodenal malignancy and active gastriculceration,
Pre-existing esophageal stenosis/stricture preventing the advancement of anendoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
Presence of any gastric condition which required endoscopic surveillance (e.g.,known gastric intestinal metaplasia),
Known vascular abnormalities, obligate therapeutic anticoagulation, andpregnancy/lactation
Evidence of end-stage liver disease, including portal hypertension, ascites, andcoagulopathy
Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumptionof more than 20 g/day in females and more than 30 g/day in males on average, use ofmedications with reported hepato-steatogenic effect (amiodarone, tamoxifen,estrogens), and drug-induced liver disease
Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclearantibody titer >1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsindeficiency,
Known positivity for human immunodeficiency virus, a concomitant disease withreduced life expectancy, severe psychiatric condition, drug dependence, or inabilityto provide informed consent.
The patient refuses or is unable to provide written informed consent
Prior bariatric treatment procedure
Study Design
Connect with a study center
West Virginia University
Morgantown, West Virginia 26508
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.