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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of two procedures to help people lose weight. It targets individuals with a BMI between 30 and 40 who haven't been able to lose weight through non-surgical methods. The treatment works by making the stomach smaller and removing extra tissue, which helps people eat less and feel full sooner.

Research Team

Omar Ghanem, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+