hybrid argon plasma coagulation and endoscopic sleeve gastroplasty trial

Conditions: Obesity

Summary: this study is being done to evaluate the safety and effectiveness of combined hybrid argon plasma coagulation (hapc) and endoscopic sleeve gastroplasty (esg) for weight loss and improvement in obesity-related co-morbidities compared to esg alone in participants with a bmi ≥ 30 and ≤40 kg/m² who have failed to achieve and maintain weight loss with a non-surgical program.


Eligibility criteria:
inclusion criteria: * bmi ≥ 30 and ≤40 kg/m² * willingness to comply with the substantial lifelong dietary restrictions required by the procedure. * history of failure with non-surgical weight-loss methods. * willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling. * residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow-up visits. * ability to give informed consent. * women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. exclusion criteria: * history of foregut or gastrointestinal (gi) surgery (except uncomplicated cholecystectomy or appendectomy). * prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions. * prior open or laparoscopic bariatric surgery. * prior surgery of any kind on the esophagus, stomach, or any type of hiatal hernia surgery. * any inflammatory disease of the gastrointestinal tract including severe (la grade c or d) esophagitis, barrett's esophagus, gastric ulceration, duodenal ulceration, cancer, or specific inflammatory disease such as crohn's disease or celiac disease. * potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses. * gastrointestinal stromal tumors, history of premalignant gastric lesions (intestinal metaplasia), history of familial and nan-familial adenomatous syndromes. * a gastric mass or gastric polyps \> 1 cm in size. * a hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms. * a structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope. * achalasia or any other severe esophageal motility disorder * severe coagulopathy. * insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a hgba1c≥9. * subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy. * chronic abdominal pain. * motility disorders of the gi tract such as gross esophageal motility disorders, gastroparesis or intractable constipation. * hepatic insufficiency or cirrhosis. * use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing. * active psychological issues preventing participation in a life-style modification program as determined by a psychologist. * patients unwilling to participate in an established medically supervised diet and behavior modification program, with routine medical follow-up. * patients receiving daily prescribed treatment with high dose aspirin (\> 81mg daily), anti-inflammatory agents, anticoagulants, or other gastric irritants. * patients who are unable or unwilling to take prescribed proton pump inhibitor medication. * patients who are pregnant or breast-feeding. * patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months. * subjects with severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, myocardial infarction within the past 6 months, poorly controlled hypertension, required use of nsaids. * subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications. * subjects who are taking corticosteroids, immunosuppressants, and narcotics. * symptomatic congestive heart failure, cardiac arrhythmia, or unstable coronary artery disease. * pre-existing respiratory disease such as moderate or severe chronic obstructive pulmonary disease (copd) requiring steroids, pneumonia, or cancer. * diagnosis of autoimmune connective tissue disorder (e.g. systemic lupus erythematosus, scleroderma) or immunocompromised. * specific diagnosed genetic disorder such as prader willi syndrome. * eating disorders including night eating syndrome (nes), bulimia, binge eating disorder, or compulsive overeating. * known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism. * at the discretion of the pi for subject safety * if minority inclusion population target of 10% has not been reached by the 90% enrollment mark (example 21 of 24 subjects), the remaining enrollments will be reserved for minority subjects (example 3 of 24 subjects).

Keywords: esg hybrid apc