62 Participants NeededMy employer runs this trial

Endoscopic Sleeve Gastroplasty + Fundal Mucosal Ablation for Obesity

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Overseen ByZim Warda Hasan
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: West Virginia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with obesity lose weight. It tests whether adding fundal mucosal ablation (FMA) to endoscopic sleeve gastroplasty (ESG), a procedure that reduces stomach size, can enhance weight loss and increase feelings of fullness. Individuals with a BMI of 30 or more who have struggled with weight loss through diet or exercise may be suitable candidates. Participants will receive either the combined ESG and FMA treatment or ESG alone to compare results. The main goal is to determine which approach leads to better weight loss and health improvements over a year. As an unphased trial, this study offers participants the chance to contribute to innovative obesity treatments and potentially improve their own health outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that these procedures are safe for weight loss in adults with obesity?

Research has shown that both treatments in this trial have strong safety records. Endoscopic Sleeve Gastroplasty (ESG) has been studied with many participants, and results indicate that ESG effectively treats obesity with a low rate of serious side effects, between 1.4% and 2.3%. This procedure is not surgery and is associated with long-term weight loss.

Fundal Mucosal Ablation (FMA) uses a method called Hybrid Argon Plasma Coagulation to help reduce hunger. Studies suggest that FMA is safe, with most patients experiencing only mild, short-term discomfort. Past research has combined this procedure with ESG, demonstrating it as a safe addition.

Overall, previous studies have shown positive safety results for both ESG and FMA, making them promising options for those considering joining this clinical trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a less invasive option for tackling obesity. Endoscopic Sleeve Gastroplasty (ESG) alone is already a minimally invasive procedure that reduces the size of the stomach without the need for surgery, which can mean fewer complications and faster recovery compared to traditional bariatric surgeries like gastric bypass. The addition of Fundal Mucosal Ablation to ESG is particularly intriguing as it may enhance weight loss results by targeting the stomach lining to further influence hunger hormones. This combination has the potential to provide a powerful, non-surgical alternative for individuals struggling with obesity, offering a potentially quicker path to weight loss with reduced risk.

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

Research has shown that Endoscopic Sleeve Gastroplasty (ESG), which participants in this trial may receive, can lead to significant weight loss. Patients typically lose 15% to 20% of their body weight within 12 to 24 months. Many also experience improvements in obesity-related conditions, such as high blood pressure and type 2 diabetes. Studies indicate that ESG is safe and effective, with lasting results when combined with lifestyle changes.

Another treatment option in this trial is the combination of ESG with Fundal Mucosal Ablation (FMA). Early studies suggest that FMA may boost weight loss by reducing hunger. FMA targets and removes areas in the stomach that produce ghrelin, a hormone that increases appetite. While the data is still emerging, this combination could potentially enhance the effectiveness of ESG alone.56789

Who Is on the Research Team?

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Shailendra Singh, MD, FASGE

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older with obesity (BMI of at least 30) who have tried but not succeeded in losing weight. Participants should be generally healthy enough for an endoscopic procedure and willing to follow up after the treatment.

Inclusion Criteria

Willing and able to comply with all study requirements including signing informed consent, routine follow-up visits, completing required assessments, and participating in dietary counseling
I am 18 years old or older.
Subjects with a BMI ≥30 kg/m²
See 3 more

Exclusion Criteria

Pregnancy, breastfeeding, or any condition making participation unsafe or interfering with study procedures as judged by investigator
I have a structural abnormality that makes procedures or endoscopy risky or difficult.
Conditions affecting weight or eating behavior including GI motility disorders, gastroparesis, chronic abdominal pain, eating disorders, or active psychological conditions
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Endoscopic Sleeve Gastroplasty (ESG) alone or ESG with Fundal Mucosal Ablation (FMA) under general anesthesia

1 day
1 visit (in-person)

Post-procedure Care

Participants receive standard post-procedure care following the ESG or ESG with FMA procedure

1-2 weeks

Follow-up

Participants are monitored for safety, effectiveness, and metabolic outcomes after the procedure

52 weeks
Multiple visits over 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Endoscopic Sleeve Gastroplasty (ESG)
  • Fundal Mucosal Ablation (FMA)

Trial Overview

The study compares two procedures: standard endoscopic sleeve gastroplasty (ESG), which reduces stomach size, versus ESG plus fundal mucosal ablation (FMA), a technique that targets hunger hormones. Participants are randomly assigned to one group on the day of their procedure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ESG with Fundal Mucosal AblationExperimental Treatment2 Interventions
Group II: Endoscopic Sleeve Gastroplasty (ESG) AloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials
192
Recruited
64,700+

Citations

Practice patterns and outcomes of endoscopic sleeve ... - PMC

Our data from a large US cohort showed significant and sustained weight loss with ESG and excellent safety profiles for both bariatric surgery and ...

Endoscopic Sleeve Gastroplasty Effective for 10 Years in ...

At 10 years, 44 patients (10.9%) achieved endoscopic revision with retightening or resuturing. The rate of moderate adverse events (AE) was 0. ...

Key Evidence on Endoscopic Sleeve Gastroplasty (ESG)

Overall patients attained the highest %TBWL (18.4% at 12 months, >20% at 24 months), reducing BMI to the class II range by six months. Safety was consistent ...

S2079 Long-Term Results of Endoscopic Sleeve... - Browse

Overall, 58% (44/76) of patients showed an %EWL >25% at 30-36 months of follow-up, 71% (54/76) of subjects showed a %TBWL > 5% 2 years after ESG,

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.

S2063 Ten-Year Outcomes of Endoscopic Sleeve... - Browse

Our results suggest that ESG is effective and safe for treatment of obesity, with durable long- term results for at least up to 10 years after the procedure.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31932205/

Safety and efficacy of endoscopic sleeve gastroplasty ...

Results: Eight observational studies with 1859 patients were included. Pooled mean percent total weight loss at 6, 12, and 24 months was 14.86 (95% confidence ...

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 ...

Endoscopic sleeve gastroplasty and its role in the ...

Though these reports suggest that ESG is effective for patients with class III obesity, the majority of published data evaluated outcomes in patients undergoing ...