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 range
21 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.