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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for weight loss by combining two procedures. It integrates endoscopic sleeve gastroplasty, a common weight-loss technique that reduces stomach size without surgery, with hybrid argon plasma coagulation, which uses heat to treat tissues. The researchers aim to determine if this combination is safer, more effective, and longer-lasting for weight loss compared to the traditional method alone. Individuals who have struggled with weight loss despite other methods, have a BMI between 30 and 40, and are willing to commit to lifestyle changes might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative weight-loss solutions.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as high-dose aspirin, anti-inflammatory agents, anticoagulants, weight-loss medications, and some others. If you're on these or similar medications, you may need to stop them to participate.

What prior data suggests that the HAPC-ESG procedure is safe for weight loss?

Research has shown that hybrid argon plasma coagulation (HAPC) is generally safe. Past studies found it effective for certain conditions when patients receive ongoing monitoring. However, risks include the possibility of a small tear or hole in the stomach, narrowing of the stomach, and growth of new tissue over existing areas. Despite these risks, most people tolerate the procedure well.

Endoscopic sleeve gastroplasty (ESG), in use since 2013, is a popular weight-loss procedure and is generally considered safe and effective. Combining HAPC with ESG aims to enhance weight-loss results while maintaining safety as a priority. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for obesity because they offer innovative approaches to weight loss. Hybrid Argon Plasma Coagulation (HAPC) combined with Endoscopic Sleeve Gastroplasty (ESG) involves ablating the gastric mucosa and then reshaping the stomach endoscopically, potentially enhancing weight loss outcomes compared to traditional methods like diet, exercise, or bariatric surgery. ESG alone, used as an active comparator, already offers a less invasive alternative to surgical options by reshaping the stomach via endoscopy without external incisions. These methods aim to provide effective, minimally invasive options with quicker recovery times, distinguishing them from more invasive surgical procedures.

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

Research shows that endoscopic sleeve gastroplasty (ESG) is the most common weight-loss procedure using an endoscope. It effectively reduces stomach size, helping people eat less and lose weight over time.

In this trial, one group of participants will receive ESG alone, while another group will receive a combination of ESG and hybrid argon plasma coagulation (HAPC). Early studies suggest that adding HAPC to ESG might enhance results. HAPC has demonstrated safety and effectiveness in other treatments, with a good safety record and potential for better outcomes. This combination could lead to more weight loss and longer-lasting effects compared to ESG alone. ^{1 2 3 5 6}

Who Is on the Research Team?

Christopher E McGowan, MD, MSCR

Principal Investigator

CEO/Medical Director

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5718177/

Hybrid Argon Plasma Coagulation in Patients With Barrett ... OP Initial data demonstrate that hybrid APC is safer compared with conventional APC due to the cushion created by the injected saline as well as the ability to ...

2. synapse.koreamed.org synapse.koreamed.org/upload/synapsexml/3027ce/pdf/ce-2022-179.pdf

Hybrid argon plasma coagulation in Barrett's esophagus Treatment with hybrid-APC consisted of a submucosal saline injection using a high-pressure water jet system, followed by application of pulsed ...

3. 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 ...

4. researchgate.net researchgate.net/publication/374506061_Efficacy_and_Safety_of_Argon_Plasma_Coagulation_for_the_Ablation_of_Barrett's_Esophagus_A_Systemic_Review_and_Meta-Analysis

(PDF) Efficacy and Safety of Argon Plasma Coagulation for ... Conclusions: High-power and hybrid APC seem to have an advantage over standard APC in terms of clearance rate and recurrence rate. Further ...

5. 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 ...

6. 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 ... The purpose of this research is to evaluate the clinical safety, durability, and weight loss outcomes of the hybrid argon plasma coagulation ...