Hybrid Argon Plasma Coagulation + Endoscopic Sleeve Gastroplasty for Obesity

(HAPCET Trial)

Overseen By Abu Dayyeh Lab

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Proton pump inhibitors

Must not be taking: Weight-loss drugs, Corticosteroids

Disqualifiers: GI surgery, Insulin-dependent diabetes, Severe cardiopulmonary disease, Eating disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help people lose weight and address health issues related to obesity. It compares two methods: one group receives both Hybrid Argon Plasma Coagulation (a treatment using gas to remove tissue) and Endoscopic Sleeve Gastroplasty (a procedure that reduces stomach size), while the other group receives only the sleeve procedure. The researchers aim to determine if the combination is more effective than the single procedure. The trial seeks participants with a BMI between 30 and 40 who have struggled to lose weight with non-surgical methods and are willing to follow strict dietary guidelines. As an unphased trial, it offers a unique opportunity to explore innovative weight loss treatments.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as high-dose aspirin, anti-inflammatory agents, anticoagulants, weight-loss medications, corticosteroids, immunosuppressants, and narcotics. If you are on these medications, you may need to discuss alternatives with your doctor before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining Hybrid Argon Plasma Coagulation (HAPC) with Endoscopic Sleeve Gastroplasty (ESG) is generally safe for people with obesity. In past studies, patients tolerated the procedures well, and serious side effects were rare. Using HAPC before ESG might help strengthen the stomach lining, potentially improving the procedure's long-term success.

Most participants in these studies experienced minor side effects like nausea or a sore throat, which typically resolved on their own. Both procedures have approval for individual use, enhancing confidence in their safety. Overall, the research suggests these treatments are safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining Endoscopic Sleeve Gastroplasty (ESG) with Hybrid Argon Plasma Coagulation (HAPC) because it could offer a more effective approach to treating obesity. Unlike traditional weight-loss surgeries that are more invasive, ESG is a minimally invasive procedure that reduces the stomach size, and adding HAPC could enhance its effectiveness by further modifying the stomach lining to promote weight loss. This combination could potentially lead to better long-term results with fewer risks and recovery time compared to standard surgical options like gastric bypass or sleeve gastrectomy.

What evidence suggests that this trial's treatments could be effective for obesity?

Research shows that Endoscopic Sleeve Gastroplasty (ESG) effectively aids weight loss in individuals with obesity. Studies have found that ESG can lead to significant weight reduction and improve related health issues. In this trial, some participants will receive ESG alone, while others will receive a combination of ESG and Hybrid Argon Plasma Coagulation (HAPC). Early results suggest that HAPC might enhance weight loss by prolonging the stomach's new shape after ESG. While HAPC has shown promise in treating other conditions, its full effect on weight loss remains under study. Overall, combining ESG with HAPC might offer a new approach to managing obesity. ^{2 6 7 8 9}

Who Is on the Research Team?

Omar Ghanem, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with obesity (BMI between 30 and 40) who haven't succeeded in losing weight through non-surgical methods. They must be willing to follow strict lifelong dietary changes, live near the investigator's office for follow-ups, and women of childbearing age should use birth control. Exclusions include those with serious heart conditions, prior GI surgeries, insulin-dependent diabetes, psychological issues affecting lifestyle changes, or severe diseases.

Inclusion Criteria

I agree to use birth control if I can have children.

I have tried losing weight without surgery but it didn't work.

Ability to give informed consent

Exclusion Criteria

I take medications that could be affected by how quickly my stomach empties.

I cannot or will not take proton pump inhibitor medication.

At the discretion of the PI for subject safety

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ESG with or without HAPC for weight loss and improvement in obesity-related co-morbidities

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of weight loss and co-morbidities

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Sleeve Gastroplasty
• Hybrid Argon Plasma Coagulation

Trial Overview The study compares the effectiveness of two procedures: Hybrid Argon Plasma Coagulation combined with Endoscopic Sleeve Gastroplasty (HAPC+ESG) versus ESG alone. The goal is to see which method is better at helping participants lose weight and improve health problems related to obesity.

How Is the Trial Designed?

Group I: Treatment Group: ESG + HAPC Experimental Treatment 1 Intervention

Subjects will undergo ESG as approved and on-label while also utilizing Hybrid APC approved and on-label.

Group II: Control Group: ESG Active Control 1 Intervention

Subjects will undergo ESG utilizing approved device alone

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Erbe Elektromedizin GmbH

Industry Sponsor

Trials

14

Recruited

840+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8671001/

Benefit, tolerance, and safety of hybrid argon plasma ... Hybrid APC appears to be promising for treatment of BE. The ablation protocol used in this study demonstrated efficacy, tolerability, and a safety profile ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05870943/hybrid-argon-plasma-coagulation-and-endoscopic-sleeve-gastroplasty-validation-study?q=argon%20plasma%20coagulation

Hybrid Argon Plasma Coagulation and Endoscopic Sleeve ... In this study, the investigators propose to evaluate the durability of endoscopic plications, weight loss outcomes, and improvements in obesity ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9839426/

Efficacy of the argon plasma coagulation in patients with ... The present study aimed to evaluate the efficacy of the APC in patients with weight regain in the postoperative periods of gastric bypass.

4. ijgii.org ijgii.org/journal/view.html?doi=10.18528/ijgii200050

Safety and long-term efficacy of hybrid-argon plasma ... Conclusion: In this prospective pilot study, hybrid-APC appears safe, feasible and effective after 24 months, which has not been evaluated so ...

5. medicalandresearch.com medicalandresearch.com/assets/articles/documents/DOCUMENT_175324782968807055e20e8MARGS_247.pdf

MAR Gastroenterology (2025) 4:04 Case Series Hybrid APC combines a submucosal saline injection with APC technology, offering the potential for safer and more effective ablation. Given the ...

6. clinicaltrial.be clinicaltrial.be/en/details/14449?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Hybrid Argon Plasma Coagulation and Endoscopic Sleeve ... This study is being done to evaluate the safety and effectiveness of combined Hybrid Argon Plasma Coagulation (HAPC) and Endoscopic Sleeve ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06790329

NCT06790329 | ESG With Fundal Mucosal Ablation This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG- ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9716477/

Argon plasma coagulation prior to endoscopic sleeve ... The combination of APC prior to endoscopic suturing potentially enhances the durability of the ESG by inducing more fibrosis in the stomach.

9. ifso.com ifso.com/pdf/martina-de-siena.pdf

a pilot study to evaluate the efficacy and safety of gastric ... Pilot, interventional, single-center study. • 20 patients → BMI ≥ 30 and ≤ 39.9 kg/m2. • HybridAPC will be applied to the gastric fundus post ESG procedure ...