Faesiblity and Safety of Endoscopic sLeeve gastrOplasty in Patients With obEsity and nflammatoRy Bowel Disease

Prior treatment

• Previous bariatric surgery or any other type of surgery that causes alteration of the lumen of the esophagus, stomach and duodenum
• Drug or alcohol abuse
• Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered
• Active IBD as defined by HBI \>4 for patients with Crohn's disease OR by partial Mayo score \>1 with rectal bleeding subscore ≥1 for patients with ulcerative colitis OR by the concomitant use of systemic steroids to control disease activity in both Crohn's disease and ulcerative colitis

Other illness

• Active Helicobacter pylori infection, causing erosions or ulcers of the stomach or duodenum.
• Organic or motility disorder of the stomach and / or esophagus
• Ongoing or active malignancy during the last 5 years.
• Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification.
• Uncontrolled thyroid disease
• Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.

Lab values

• Liver cirrhosis of any Child-Pugh stage or MELD\> 15 Chronic Severe Renal Insufficiency (eGFR \< 30 ml/min/1.73 m2 based on CKD-EPI equation)

Other

• Bulimic or binge eating pattern
• Pregnancy, breastfeeding
• Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

• Age 18 to 70 years
• BMI between 30 to 40 kg/m2
• Willingness to participate in the study and ability to comply and understand the study protocol
• Patients with steroid-free clinical remission of IBD for at least 6 months before screening as defined by HBI ≤4 for patients with Crohn's disease OR by partial Mayo score (3-point Mayo score) ≤1 with rectal bleeding subscore =0 for patients with ulcerative colitis AND no use of systemic steroids during the 6 months before screening
• Patients with a previous diagnosis of Crohn's disease or Ulcerative colitis at least 3 months before screening
• Patients with stable maintenance therapy for IBD, meaning a stable dose of mesalamine, immunosuppressants of biological drugs for at least 8 weeks before ESG (baseline).