iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) vs Optimized Lifestyle Intervention for Weight Loss

Exclusion Criteria31

• Prior gastrointestinal surgery with clinically relevant sequelae.
• Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric/duodenal ulcer), or neoplastic lesions.
• Any condition associated with an increased risk of upper gastrointestinal bleeding.
• Hiatal hernia \>2 cm or severe/refractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.
• Esophageal/pharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum).
• Achalasia or other severe esophageal motility disorder.
• Severe coagulopathy.
• Insulin-dependent diabetes mellitus.
• Chronic abdominal pain.
• Gastrointestinal motility disorder (e.g., gastroparesis).
• Hepatic impairment or cirrhosis.
• Severe or uncontrolled psychiatric illness.
• Alcohol abuse or substance dependence.
• Unwilling to participate in a physician-supervised diet/behavior modification program and/or unwilling to comply with routine follow-up.
• Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating medications.
• Unable or unwilling to take proton pump inhibitor (PPI) therapy as prescribed during the treatment period.
• Known or suspected hypersensitivity to any material/component of the study system.
• Pregnant or breastfeeding.
• Severe cardiopulmonary disease or other serious systemic/organic disease.
• Positive Helicobacter pylori (H. pylori) test.
• Use of time-critical medications potentially affected by altered gastric emptying (e.g., antiepileptics, antiarrhythmics).
• Current systemic corticosteroids, immunosuppressants, or opioid analgesics.
• Use of any weight-loss medication within the past 3 months or current use.
• Prior use of any intragastric device.
• Participation in a weight-affecting clinical trial within the past 6 months.
• Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable coronary artery disease.
• Clinically significant respiratory disease.
• Autoimmune connective tissue disease.
• Life expectancy \<1 year or severe renal/hepatic/pulmonary or other serious medical illness.
• Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi syndrome) or other endocrine disease known to affect body weight.
• Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating disorder, compulsive eating).