HAPC-ESG for Obesity

(HAPCET2 Trial)

Overseen By Christopher McGowan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: True You Weight Loss

Must be taking: Proton pump inhibitors

Must not be taking: Weight-loss medications, Corticosteroids

Disqualifiers: GI surgery, Diabetes, Cardiopulmonary disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Christopher E McGowan, MD, MSCR

Principal Investigator

CEO/Medical Director

Eligibility Criteria

Adults aged 21-65 with a BMI between 30 and ≤40 kg/m², who have unsuccessfully tried non-surgical weight-loss methods. Participants must be willing to follow the study's diet restrictions, live near Cary, NC for follow-ups, use birth control if applicable, and have internet access. Excluded are those with certain past surgeries or conditions like severe coagulopathy, insulin-dependent diabetes (HgbA1C≥9), gastrointestinal issues including large hiatal hernias (>4cm), or on specific medications that affect gastric emptying.

Inclusion Criteria

I am between 21 and 65 years old.

Willingness to comply with substantial lifelong dietary restrictions required by the procedure

Ability to give informed consent

Exclusion Criteria

I do not have severe digestive system conditions like Crohn's or celiac disease.

I have conditions that could cause bleeding in my upper digestive tract.

I have a large hiatal hernia or severe acid reflux that's hard to control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty (HAPC-ESG) or Endoscopic Sleeve Gastroplasty (ESG) alone

6 months

Follow-up

Participants are monitored for safety, durability, and weight loss outcomes after treatment

6 months

Treatment Details

Interventions

• Endoscopic Sleeve Gastroplasty
• Hybrid Argon Plasma Coagulation

Trial Overview The trial is testing a new procedure combining Hybrid Argon Plasma Coagulation (HAPC) with Endoscopic Sleeve Gastroplasty (ESG) against the standard ESG alone. The goal is to see if adding HAPC improves weight loss outcomes and durability of the treatment compared to just using ESG.

Participant Groups

Group I: Hybrid Argon Plasma Coagulation and Endoscopic Sleeve Gastroplasty Experimental Treatment 2 Interventions

Hybrid APC will be utilized to first ablate the gastric mucosa along the greater curve of the stomach, followed immediately by endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.

Group II: Endoscopic Sleeve Gastroplasty Active Control 1 Intervention

Endoscopic full-thickness tissue acquisition and plication using 2-0 Prolene synthetic sutures via the Apollo ESG platform.

Who Is Running the Clinical Trial?

True You Weight Loss

Lead Sponsor

Trials

5

Recruited

370+

Apollo Endosurgery, Inc.

Industry Sponsor

Trials

13

Recruited

2,900+

Erbe USA Incorporated

Collaborator

Trials

12

Recruited

1,300+

Erbe Elektromedizin GmbH

Industry Sponsor

Trials

14

Recruited

840+