Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Trial
United States45 participantsStarted 2022-11-18
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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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 o…