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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new weight loss method that combines fundic ablation and endoscopic sleeve gastroplasty (ESG). The goal is to reduce ghrelin levels, a hormone linked to hunger and weight gain, and to help participants feel full faster. This combined approach might lead to better weight loss results than traditional ESG alone. Individuals with a BMI of 30 to 50, who have unsuccessfully tried diets before, and can travel to Cary, North Carolina, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative weight loss techniques before they become widely available.

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 prior data suggests that this procedure is safe for obesity treatment?

Research has shown that combining fundic ablation (FA) and endoscopic sleeve gastroplasty (ESG) is being studied for their effects on weight loss and appetite control. These procedures have been found to lower levels of ghrelin, a hormone linked to hunger and weight gain.

Regarding safety, studies on these combined treatments are still gathering information. Since they are in the early stages, knowledge about possible side effects remains limited. Researchers are also still learning about treatment tolerance.

While the procedure targets parts of the stomach to help control appetite, like any medical treatment, risks may exist. It is important to consult healthcare professionals to understand the potential benefits and risks before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of fundic ablation and endoscopic sleeve gastroplasty (ESG) for obesity because it offers a novel approach compared to traditional bariatric surgeries, which often involve major surgery and longer recovery times. This treatment is unique as it uses an endoscopic technique, meaning it's less invasive and can be done in a single session. Fundic ablation specifically targets the stomach lining to potentially reduce hunger signals, while ESG reshapes the stomach to limit food intake. Together, these techniques could provide a more efficient and patient-friendly option for weight loss.

What evidence suggests that this combined treatment could be effective for obesity?

Research has shown that combining fundic ablation (FA) with endoscopic sleeve gastroplasty (ESG), as studied in this trial, might aid in weight loss. Studies have found that this combined treatment can lower levels of ghrelin, a hormone that increases hunger. With reduced ghrelin, individuals may feel full sooner and eat less. Early results suggest this method could lead to significant weight loss, with some studies targeting a total body weight loss (TBWL) of 15% or more. This makes the treatment a promising option for managing obesity. ^{1 2 3 4 5}

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 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

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

I am between 21 and 65 years old.

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

Exclusion Criteria

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

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

I am currently taking medication to help me lose weight.

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 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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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) 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) 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 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]

Citations

1. 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, ...

2. 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 ...

3. 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 ...

4. withpower.com withpower.com/trial/phase-2-weight-loss-10-2023-409f9

Combined Ablation and ESG for Obesity · Info for Participants The purpose of this research is to investigate the effects of fundic ablation (FA) on circulating plasma ghrelin, satiation, and total body weight loss, ...

5. 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, ...