Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study (NCT05870943) | Clinical Trial Compass
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Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Validation Study
United States48 participantsStarted 2023-05-18
Plain-language summary
The purpose of this research is to evaluate the clinical safety, durability, and weight loss outcomes of the hybrid argon plasma coagulation + endoscopic sleeve gastroplasty (HAPC-ESG) procedure when compared to traditional endoscopic sleeve gastroplasty (ESG) alone. ESG was proven to be feasible in human subjects in 2013 and since then has become the most commonly performed endoscopic bariatric remodeling procedure. However, this procedure may be enhanced with the addition of the hybrid argon plasma coagulation (HAPC) technique, leading to enhanced weight loss, durability, and metabolic benefits. Argon plasma coagulation (APC) is a method of non-contact thermal hemostasis initially created to assist in inducing hemostasis utilizing a high-frequency current to the targeted area. This is a validation study of a pilot randomized control trial which will evaluate the safety, durability, and effects on weight loss of the combined HAPC-ESG approach when compared to traditional ESG alone.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age 21-65
✓. 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 driving distance from the investigator's office (Cary, NC) and able to travel to the investigator to complete all routine follow-up visits as applicable
✓. 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).
What they're measuring
1
Durability assessed by blinded physician(s) with expertise in endoscopic sleeve gastroplasty (ESG) procedures graded according to a priori standardized criteria.
✕. 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.