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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for obesity that combines two procedures: fundic ablation and endoscopic sleeve gastroplasty (ESG). The goal is to determine if this combination can better control appetite and lead to more weight loss by reducing levels of ghrelin, a hormone that increases hunger. It suits individuals who have unsuccessfully tried to lose weight through dieting and have a BMI between 30 and 50. Participants must be able to travel to Cary, North Carolina, and have internet access. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in obesity treatment.

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.

What prior data suggests that this combined ablation and ESG procedure is safe for obesity treatment?

Research has shown that fundic ablation (FA), when combined with endoscopic sleeve gastroplasty (ESG), is generally well-tolerated. One study on the safety and practicality of this procedure found it safe for participants, who did not experience any serious side effects.

Although researchers are still studying this treatment, current data suggests a low risk of serious side effects. This new approach aims to lower the hormone ghrelin, which stimulates hunger. By reducing this hormone, the treatment helps control hunger and supports weight loss.

Overall, evidence so far indicates that combining fundic ablation with ESG is safe. However, like any new treatment, ongoing research will continue to assess its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of gastric fundic ablation and endoscopic sleeve gastroplasty for obesity because it offers a novel approach to weight loss. Unlike traditional surgical options like gastric bypass or lap band surgery, this method uses a minimally invasive endoscopic technique, which can potentially reduce recovery time and complications. Fundic ablation targets the stomach's fundus, the area responsible for the production of the hunger hormone ghrelin, thus potentially reducing appetite more effectively. Combining this with endoscopic sleeve gastroplasty, which reshapes the stomach to limit food intake, could provide a powerful one-two punch in managing obesity with fewer risks than major surgery.

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

Research shows that Endoscopic Sleeve Gastroplasty (ESG), one of the treatments in this trial, aids in weight loss. Studies indicate it typically results in a 13% to 20% reduction in total body weight within a year. Additionally, fundic ablation (FA), also part of this trial, aims to reduce ghrelin, a hormone that triggers hunger. Early research suggests that combining FA with ESG, as studied in this trial, might further lower ghrelin levels, enhance feelings of fullness, and improve weight loss outcomes. This combination could prove more effective than ESG alone. ^{6 7 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12566468/

Outcomes of Endoscopic Sleeve Gastroplasty In summary, ESG consistently results in substantial weight loss—typically from 13% to 20% TBWL at 12 months—with additional benefits including ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06339320

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of ... Apollo ESG is the first and only device to be authorized by the FDA to perform the ESG procedure to facilitate weight loss in patients with obesity (BMI 30 to ...

3. gi.org gi.org/journals-publications/ebgi/kolb_chiang_feb2023/

Endoscopic Sleeve Gastroplasty Is Effective for Patients ... ESG has been performed worldwide and consistently demonstrated improvement in TBWL of 15%-20%. In a meta-analysis of 1,772 patients who had ESG, ...

4. cghjournal.org cghjournal.org/article/S1542-3565(20)31385-9/fulltext

Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for ... Our results suggest that ESG is safe and effective for treatment of obesity, with durable long-term results for at least up to 5 years after ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2590030724000357

Cost-Effectiveness Analysis of Endoscopic Sleeve ... This cost-effectiveness analysis suggests that ESG is cost effective in 5 years and cost saving over a lifetime for patients with obesity and type 2 diabetes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05578703

ABLATE WEIGHT (Ablation Plus ESG for Weight Loss) The purpose of this research is to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation, and total body weight loss, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05992103

NCT05992103 | ABLATE WEIGHT 2 (Single-Stage Fundic ... The purpose of this research is to investigate the combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty on circulating plasma ghrelin ...

8. gastrojournal.org gastrojournal.org/article/S0016-5085(24)05349-6/abstract

Endoscopic Gastric Fundal Mucosal Ablation Induces ... We conducted a first-in-human study of GFMA to appraise its safety, feasibility, and the mechanistic underpinnings of appetite control.

9. clinicaltrial.be clinicaltrial.be/en/details/83166?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

ABLATE WEIGHT (Ablation Plus ESG for Weight Loss) This study hypothesizes that, compared to baseline, FA-ESG will diminish fasting ghrelin levels, improve satiation, and induce a TBWL ≥ 15% at ...

10. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05992103/ablate-weight-2-single-stage-fundic-ablation-plus-esg-for-weight-loss

ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ... The purpose of this research is to investigate the combined effects of fundic ablation (FA) and endoscopic sleeve gastroplasty on circulating plasma ghrelin, ...