Combined Fundic Ablation and ESG for Obesity

(AW2 Trial)

Overseen By Christopher E McGowan, MD, MSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: True You Weight Loss

Must not be taking: Anticoagulants, Opiates, Anticholinergics, others

Disqualifiers: Gastroparesis, Stomach manipulation, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to investigate the combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty on circulating plasma ghrelin, satiation, and total body weight loss, as well as the incidence of adverse events. This procedure will be carried out with the HybridAPC (ERBE Elektromedizin GmbH, Tübingen, Germany). The HybridAPC instrument creates an electric current to deliver a safe amount of thermal injury to a portion of the stomach known as the gastric fundus. This thermal injury will target a hormone called ghrelin which is the only known hormone linked to increasing appetite, calorie intake, and weight gain. This procedure is designed to target the bodily effects of appetite control and gastric sensory and motor functions which cause the feeling of fullness and satiation. When fundic mucosal ablation is paired with endoscopic sleeve gastroplasty (ESG), this combined investigational approach may lead to decreased fasting ghrelin levels, improved satiation, and greater total body weight loss than traditional ESG. This study will help determine if the combined impact of FA with ESG within the same endoscopic session should be made available to patients as part of a comprehensive weight loss strategy.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants on medications that affect hormones like insulin or those that impact stomach function, such as certain antidepressants and drugs for gastric issues. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Combined Fundic Ablation and ESG for Obesity?

Endoscopic sleeve gastroplasty (ESG), a part of this treatment, has been shown to be effective in reducing stomach size and aiding weight loss in people with obesity. Studies have demonstrated that ESG is a safe and effective procedure for managing obesity, leading to weight loss and improvement in obesity-related health issues. ^{1 2 3 4 5}

Is the combined fundic ablation and ESG procedure safe for humans?

Endoscopic sleeve gastroplasty (ESG) is generally considered a safe procedure for treating obesity, as it is minimally invasive and has been associated with weight loss and improvement in obesity-related conditions. ^{1 3 4 5 6}

How is the treatment of Fundic Ablation combined with Endoscopic Sleeve Gastroplasty different from other obesity treatments?

This treatment is unique because it combines fundic ablation, which targets the upper part of the stomach to reduce hunger, with endoscopic sleeve gastroplasty (ESG), a minimally invasive procedure that reduces stomach size without incisions. This combination aims to enhance weight loss by addressing both appetite and stomach capacity, unlike traditional surgical options that typically focus on one aspect. ^{2 3 4 7 8}

Eligibility Criteria

This trial is for adults aged 21-65 with a BMI of 30-50 who have tried and failed to lose weight through dieting. They must be able to travel to Cary, North Carolina, have internet access, and not be pregnant or planning pregnancy during the study. Exclusions include prior stomach surgery, certain medical conditions like uncontrolled diabetes or gastroparesis, use of specific medications affecting digestion or blood clotting, and allergies to milk/soy.

Inclusion Criteria

I am between 21 and 65 years old.

Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≤50 kg/m²

I can travel to and from Cary, North Carolina easily.

Exclusion Criteria

Patients who are pregnant or who plan to become pregnant during study duration

I am currently taking medication to help me lose weight.

I have a history of stomach or bowel problems like IBS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in total body weight and occurrence of adverse events

12 months

Monthly visits (in-person or virtual)

Treatment Details

Interventions

• Apollo ESG
• Fundic Ablation in Combination with Endoscopic Sleeve Gastroplasty
• Fundic Mucosal Ablation with ERBE HybridAPC

Trial Overview The trial tests a combined procedure for weight loss: fundic ablation (FA) plus endoscopic sleeve gastroplasty (ESG). FA uses thermal injury on the stomach's gastric fundus to reduce ghrelin hormone levels that increase appetite. ESG reshapes the stomach. Together they aim to enhance satiation and promote more weight loss than ESG alone.

Participant Groups

Group I: Single-Stage Gastric Fundic Ablation plus Endoscopic Sleeve Gastroplasty Experimental Treatment 3 Interventions

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty in the same endoscopic session

Who Is Running the Clinical Trial?

True You Weight Loss

Lead Sponsor

Trials

5

Recruited

370+

Findings from Research

Endoscopic sleeve gastroplasty (ESG) is a safe and effective procedure for obesity, showing significant weight loss results with a mean BMI reduction of 9.3 kg/m2 at 6 months and sustained excess body weight loss of 35.6% at 6 months post-procedure.

The study involved 91 patients across six centers, demonstrating that ESG can be successfully implemented in new endobariatric programs, with a mean procedure duration of 85.1 minutes and a short hospital stay of about 27 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study. Sarkar, A., Tawadros, A., Andalib, I., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) is a safe and effective procedure for overweight patients, with a low adverse event rate of only 1.5% and successful completion of all procedures in a study of 189 patients.

Patients experienced significant weight loss, with a mean total weight loss of 12.28% at 6 months and high rates of BMI normalization (76% at 12 months and 86% at 24 months), suggesting ESG can effectively help prevent the progression to obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population. Brunaldi, VO., Galvao Neto, M., Sharaiha, RZ., et al.[2023]

Endoscopic sleeve gastroplasty (ESG) resulted in a lower percentage of total body weight loss (17.57%) compared to laparoscopic sleeve gastrectomy (LSG) (29.28%) at 12 months, but it was associated with significantly lower morbidity and shorter hospital stays.

ESG demonstrated a mean length of stay of just 0.34 days, much shorter than LSG (3.09 days) and laparoscopic adjustable gastric banding (LAGB) (1.66 days), making it a safer and more convenient option for select patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? Novikov, AA., Afaneh, C., Saumoy, M., et al.[2019]

Endoscopic sleeve gastroplasty (ESG) led to significant weight loss and improved glycemic control over a 24-month follow-up in 20 patients, with the most notable improvements occurring six months post-procedure.

Unlike traditional surgical methods, ESG did not result in deficiencies in essential vitamins, indicating a safer profile while effectively altering glucose metabolism and positively affecting body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional consequences of endoluminal gastroplasty in the treatment of morbidly obese patients. Svagera, Z., Machytka, E., Machackova, J., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) is increasingly used to treat obesity-related issues, but the current literature lacks randomized trials, with 37 studies reviewed showing a wide range of patient numbers and follow-up durations.

The studies reported various technical aspects of ESG, including suturing techniques, but highlighted the need for more standardized reporting and a randomized controlled trial to better assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Innovation Reporting in Endoscopic Sleeve Gastroplasty. Currie, AC., Glaysher, MA., Blencowe, NS., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) is an effective minimally invasive procedure for weight loss, resulting in an average total body weight loss of 20.9% over 24 months in a study of 91 patients with a mean BMI of 40.7 kg/m2.

ESG significantly improved obesity-related health markers, including reductions in hemoglobin A1c, systolic blood pressure, waist circumference, and serum triglycerides, while demonstrating a low safety profile with only one serious adverse event (1.1%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Sharaiha, RZ., Kumta, NA., Saumoy, M., et al.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty: A Practice Pattern Survey. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of endoscopic sleeve gastroplasty for obesity management in new bariatric endoscopy programs: a multicenter international study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? [2019]

5. Czech Republic pubmed.ncbi.nlm.nih.gov

Nutritional consequences of endoluminal gastroplasty in the treatment of morbidly obese patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Innovation Reporting in Endoscopic Sleeve Gastroplasty. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A single-operator learning curve analysis for the endoscopic sleeve gastroplasty. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. [2017]