Ablation of gastric mucosa combined with endoscopic sleeve gastroplasty for obesity treatment

A Pilot Study to Evaluate the Impact of Gastric Mucosal Ablation (GMA) of the Fundus With Hybrid Argon Plasma Coagulation (HybridAPC) Combined With Endoscopic Sleeve Gastroplasty (ESG) on Obesity

This study is testing a new combined procedure of gastric mucosal ablation and endoscopic sleeve gastroplasty to see if it helps people with obesity lose weight and improve their health without needing major surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Rome)
• Trial ID: NCT06438510 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of gastric mucosal ablation using hybrid argon plasma coagulation in conjunction with endoscopic sleeve gastroplasty in obese patients. The goal is to restore ghrelin cell function in the gastric fundus, which may enhance long-term weight loss and reduce obesity-related comorbidities. Participants will undergo this combined procedure and will be monitored for changes in body weight and metabolic health. The study aims to provide a less invasive alternative to traditional bariatric surgery for patients with class I and II obesity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with class I to II obesity who have not previously undergone bariatric surgery or endoscopic therapy.

Not a fit: Patients with a BMI below 30 or above 39.9, or those who have had previous upper gastrointestinal surgery, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved weight loss and metabolic health for obese patients.

How similar studies have performed: While the combination of gastric mucosal ablation and endoscopic sleeve gastroplasty is a novel approach, similar studies have shown promising results in weight loss and metabolic improvements.

Eligibility criteria

Inclusion Criteria:

* 1\. Male or females patients in the range of class Class I to Class II obesity (30 ≤ BMI ≤ 39.9).
* Age between 18 and 65 years (both inclusive).
* Treatment naïve for bariatric surgery or endoscopic bariatric therapy.
* Patients that have been evaluated by the local MDT and have indication to ESG.
* Willingness to comply with the substantial behavioral modifications program as required by the procedure.
* Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study.
* Women of childbearing potential should have negative urine beta human chorionic gonadotropin (hCG) pregnancy test and must agree to use acceptable contraception methods throughout the study duration.
* Able to comply with study requirements and understand and sign the Informed Consent Form.

Exclusion Criteria:

* Previous upper GI surgery (except uncomplicated cholecystectomy or appendectomy), or other endoscopic bariatric procedures or conditions,
* Prior intra-gastric balloon or another gastric implant.
* History of a structural or functional disorder of the esophagus or pharynx that may impede passage of the device such as achalasia, stricture/stenosis, esophageal varices, esophageal diverticula, esophageal perforation, severe or intractable gastro-esophageal reflux symptoms while on maximal medical therapy, uncontrolled GERD defined as LA grade C esophagitis or greater.
* History of a structural or functional disorder of the stomach including gastric polyps \> 1 cm in size, gastroparesis, gastric ulcer, gastric cancer, chronic gastritis, gastric varices, hiatal hernia (\>4 cm) of axial displacement of the z-line above the diaphragm.
* Active H. pylori infection (subjects with active H. pylori may continue with the screening process if they are treated with an appropriate antibiotic regimen, and eradication has been confirmed).
* Patients with history of intestinal stricture/stenosis, small bowel or colonic obstruction or any other obstructive disorder of the GI tract such as adhesive peritonitis and/or abdominal adhesions.
* Patients with any inflammatory disease (IBD).
* Autoimmune disease, including but not limited to celiac disease, or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder.
* Active hepatitis, active liver disease, hepatic insufficiency , or cirrhosis.
* Untreated/inadequately treated hypothyroidism, defined as an elevated Thyroid-Stimulating Hormone (TSH) level at Screening; if on thyroid hormone replacement therapy, must be on stable dose for at least 6 weeks prior to Screening.
* Patients with PCOS (hormonal dis-balances).
* Persistent Anemia, defined as Hemoglobin \<10 g/dL.
* Significant cardiovascular disease including known history of valvular disease, or myocardial infarction, heart failure, transient ischemic attack or stroke within the last 6 months.
* Moderate or severe chronic kidney disease (CKD), with estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m2 (estimated by MDRD).
* Known immunocompromised status, including but not limited to individuals who have undergone organ transplantation, chemotherapy or radiotherapy within the past 12 months, who have clinically-significant leukopenia, who are positive for the human immunodeficiency virus (HIV) or whose immune status makes the subject a poor candidate for clinical trial participation in the opinion of the Investigator.
* HbA1c \> 8.5 %.
* Patients requiring exogenous insulin.
* Use of glucose-lowering drugs for diabetes mellitus treatment with the exception of sulfonylurea (SU), biguanides and sodium dependent glucose co-transporter 2 (SGLT-2) inhibitors.
* Coagulopathy, congenital or acquired intestinal telangiectasia.
* Use of systemic glucocorticoids (excluding topical or ophthalmic application or inhaled forms) for more than 10 consecutive days within 90 days prior to the Screening Visit.
* Pregnant or breast-feeding woman.
* Patients with history or current abuse of drugs or alcohol.
* Patients who are taking medications that cause weight loss such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study.
* Patients who are taking medication that cause weight gain such as anti-depressants
* Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study.
* Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.

Where this trial is running

Rome

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: ivo boskoski — Fondazione Policlinico Gemelli IRCCS
• Study coordinator: Ivo Boskoski

Conditions Obesity