Two devices may be better than one for obesity treatment
NCT ID NCT05559866
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether combining two endoscopic procedures—Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG)—is safer and more effective than ESG alone for weight loss. The trial included 45 adults with obesity (BMI 30–40) who had not succeeded with non-surgical methods. The main goal was to see if the combination made the sutures last longer at 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve Gastroplasty (ESG) devices
- What this could lead to
- If successful, this combination could make endoscopic weight-loss procedures more durable and effective for people with obesity.
- What could go wrong
- This is a small, single-center trial with only 45 participants. The primary outcome is about suture durability, not long-term weight loss, so results may not translate to lasting benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
45 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
-
Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Obesity are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which exercise dose best helps kids with metabolic syndrome?
- Custom knee guides put to the test in obese patients
- A pill for obesity? early human trial puts MDR-001 to the test
- Can a weekly shot help people who still struggle with weight after bariatric surgery?
- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?