Combined Ablation and ESG for Obesity

Overseen By Ashley M Kucera, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: True You Weight Loss

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

Disqualifiers: Gastroparesis, Stomach manipulation, Pregnancy, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 months

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to investigate the effects of fundic ablation (FA) 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. The fundic mucosal ablation is not typically done prior to the endoscopic sleeve gastroplasty procedure. When fundic mucosal ablation is sequentially 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 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 some antidepressants and drugs for gastric issues. It's best to discuss your current medications with the trial team to see if they are allowed.

Is the combined ablation and ESG treatment safe for humans?

Endoscopic sleeve gastroplasty (ESG) is generally considered safe, with a low complication rate of less than 2%. It is a minimally invasive procedure used for obesity treatment, and while rare complications like gallbladder injuries have been reported, they are uncommon. ^{1 2 3 4 5}

How is the treatment 'Combined Ablation and ESG for Obesity' different from other obesity treatments?

This treatment combines endoscopic sleeve gastroplasty (ESG), a minimally invasive procedure that reduces stomach size, with fundic mucosal ablation using ERBE HybridAPC, which induces scarring to improve the durability of the procedure. This combination aims to enhance the long-term effectiveness of ESG by preventing the stomach from enlarging again. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Apollo ESG, Fundic Ablation Sequentially in Combination with Endoscopic Sleeve Gastroplasty, Fundic Mucosal Ablation with ERBE HybridAPC for obesity?

Endoscopic sleeve gastroplasty (ESG) is shown to be an effective, minimally invasive procedure for treating mild to moderate obesity, and combining it with argon plasma coagulation (APC) may improve the durability of the treatment by inducing scarring and fibrosis, which helps maintain the stomach's reduced size. ^{5 6 8 9 10}

Who Is on the Research Team?

Christopher E McGowan, MD, MSCR

Principal Investigator

CEO/ Medical Director

Are You a Good Fit for This Trial?

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 access the internet, travel to Cary, NC, and not be on certain medications or have conditions affecting stomach function. Pregnant individuals or those planning pregnancy during the study are excluded.

Inclusion Criteria

I can travel to and from Cary, North Carolina for the trial.

I am between 21 and 65 years old.

History of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria

I am not taking buspirone or mirtazapine.

I am under 21 years old.

Milk and/or soy allergies

Timeline for a Trial Participant

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

12 months

Monthly visits for 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Bi-monthly visits

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The trial tests if fundic ablation (FA) followed by endoscopic sleeve gastroplasty (ESG) leads to better appetite control and more weight loss than ESG alone. FA targets ghrelin, a hormone that increases appetite; this combination could improve satiation and reduce body weight.

How Is the Trial Designed?

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

Subjects will undergo fundic mucosal ablation followed by endoscopic sleeve gastroplasty

Who Is Running the Clinical Trial?

True You Weight Loss

Lead Sponsor

Trials

5

Recruited

370+

Published Research Related to This Trial

Endoscopic sleeve gastroplasty using the Apollo method is a safe and effective weight loss intervention, with no major complications reported in a study of 55 patients over 6 months.

Patients experienced an average weight loss of 18.9 kg and a 55.3% reduction in excess weight, demonstrating significant efficacy when combined with dietary and psycho-behavioral support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management. López-Nava Breviere, G., Bautista-Castaño, I., Fernández-Corbelle, JP., et al.[2017]

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) is a safe and effective obesity management procedure, showing a mean total body weight loss of 18.2% over one year with a low adverse event rate of only 0.8%.

A consensus among 47 experienced endoscopists established practical guidelines for ESG, covering patient selection, procedure techniques, and follow-up, which can help standardize the approach as the number of procedures increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brazilian Consensus on Endoscopic Sleeve Gastroplasty. Neto, MG., Silva, LB., de Quadros, LG., et al.[2021]

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]

Citations

1. Spain pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management. [2017]

2. 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]

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

Obesity and GERD: pathophysiology and effect of bariatric surgery. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty with argon plasma coagulation: A novel technique. [2021]

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

Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for the Treatment of Obesity. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. [2022]

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

Brazilian Consensus on Endoscopic Sleeve Gastroplasty. [2021]

8. 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]

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

Gallbladder plication as a rare complication of endoscopic sleeve gastroplasty: A case report. [2023]

10. India pubmed.ncbi.nlm.nih.gov

An Indian Experience of Endoscopic Treatment of Obesity by Using a Novel Technique of Endoscopic Sleeve Gastroplasty (Accordion Procedure). [2022]