The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty)

Inclusion Criteria:

1. Male or females patients in the range of class Class I to Class II obesity (30 ≤ BMI ≤ 39.9).

• Age between 18 and 65 years (both inclusive).

• Treatment naïve for bariatric surgery or endoscopic bariatric therapy.

• Patients that have been evaluated by the local MDT and have indication to ESG.

• Willingness to comply with the substantial behavioral modifications program asrequired by the procedure.

• Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia,Xenical, or over the counter weight loss medications or supplements throughout thestudy.

• Women of childbearing potential should have negative urine beta human chorionicgonadotropin (hCG) pregnancy test and must agree to use acceptable contraceptionmethods throughout the study duration.

• Able to comply with study requirements and understand and sign the Informed ConsentForm.

Exclusion Criteria:

• Previous upper GI surgery (except uncomplicated cholecystectomy or appendectomy), orother endoscopic bariatric procedures or conditions,

• Prior intra-gastric balloon or another gastric implant.

• History of a structural or functional disorder of the esophagus or pharynx that mayimpede passage of the device such as achalasia, stricture/stenosis, esophagealvarices, esophageal diverticula, esophageal perforation, severe or intractablegastro-esophageal reflux symptoms while on maximal medical therapy, uncontrolledGERD defined as LA grade C esophagitis or greater.

• History of a structural or functional disorder of the stomach including gastricpolyps > 1 cm in size, gastroparesis, gastric ulcer, gastric cancer, chronicgastritis, gastric varices, hiatal hernia (>4 cm) of axial displacement of thez-line above the diaphragm.

• Active H. pylori infection (subjects with active H. pylori may continue with thescreening process if they are treated with an appropriate antibiotic regimen, anderadication has been confirmed).

• Patients with history of intestinal stricture/stenosis, small bowel or colonicobstruction or any other obstructive disorder of the GI tract such as adhesiveperitonitis and/or abdominal adhesions.

• Patients with any inflammatory disease (IBD).

• Autoimmune disease, including but not limited to celiac disease, or pre-existingsymptoms of systemic lupus erythematosus, scleroderma or other autoimmune connectivetissue disorder.

• Active hepatitis, active liver disease, hepatic insufficiency , or cirrhosis.

• Untreated/inadequately treated hypothyroidism, defined as an elevatedThyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormonereplacement therapy, must be on stable dose for at least 6 weeks prior to Screening.

• Patients with PCOS (hormonal dis-balances).

• Persistent Anemia, defined as Hemoglobin <10 g/dL.

• Significant cardiovascular disease including known history of valvular disease, ormyocardial infarction, heart failure, transient ischemic attack or stroke within thelast 6 months.

• Moderate or severe chronic kidney disease (CKD), with estimated glomerularfiltration rate (eGFR) <45 ml/min/1.73m2 (estimated by MDRD).

• Known immunocompromised status, including but not limited to individuals who haveundergone organ transplantation, chemotherapy or radiotherapy within the past 12months, who have clinically-significant leukopenia, who are positive for the humanimmunodeficiency virus (HIV) or whose immune status makes the subject a poorcandidate for clinical trial participation in the opinion of the Investigator.

• HbA1c > 8.5 %.

• Patients requiring exogenous insulin.

• Use of glucose-lowering drugs for diabetes mellitus treatment with the exception ofsulfonylurea (SU), biguanides and sodium dependent glucose co-transporter 2 (SGLT-2)inhibitors.

• Coagulopathy, congenital or acquired intestinal telangiectasia.

• Use of systemic glucocorticoids (excluding topical or ophthalmic application orinhaled forms) for more than 10 consecutive days within 90 days prior to theScreening Visit.

• Pregnant or breast-feeding woman.

• Patients with history or current abuse of drugs or alcohol.

• Patients who are taking medications that cause weight loss such as Meridia, Saxenda,Januvia, Xenical, or over the counter weight loss medications or supplementsthroughout the study.

• Patients who are taking medication that cause weight gain such as anti-depressants

• Psychiatric or cooperative problems or low compliance that is a contraindicationfrom participating in the study.

• Any health issue that might put the patient at risk if the treatment is performed,judged by the investigator.