Gastric Mucosal Ablation and Endoscopic Sleeve Gastroplasty for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new weight loss procedure that combines gastric mucosal ablation and endoscopic sleeve gastroplasty. The goal is to assess the effectiveness of this combined treatment for weight loss and health improvement. It suits individuals with a BMI between 28 and 55 who are committed to lifelong dietary changes. Participants will include those already planning to undergo this procedure at True You Weight Loss. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to groundbreaking weight loss research.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking any weight-loss medications or therapies for weight loss if you've used them in the past 6 months. For other medications, the protocol does not specify, so it's best to discuss with the trial team.
What prior data suggests that this combined gastric mucosal ablation with endoscopic sleeve gastroplasty is safe?
Research has shown that the endoscopic sleeve gastroplasty (ESG) component of this treatment is generally safe for managing obesity. Studies indicate that ESG has a safety record comparable to other procedures, such as surgical sleeve gastrectomy. It often requires less time and a shorter hospital stay.
Reports also demonstrate that ESG is effective for weight loss, with results lasting up to five years. Although all procedures carry risks, ESG is usually well-tolerated, and serious complications are rare. It is important to consult a healthcare provider to understand personal risks.12345Why are researchers excited about this trial?
The combined gastric mucosal ablation with endoscopic sleeve gastroplasty is unique because it merges two innovative techniques to enhance weight loss outcomes. Traditional weight loss methods often include lifestyle changes, medications, or bariatric surgery like gastric bypass. However, this treatment uses endoscopic procedures, which are less invasive than surgery, potentially offering faster recovery times and fewer complications. Researchers are excited about this approach because it targets the stomach lining and reshapes the stomach simultaneously, which may lead to more significant and sustained weight loss compared to current options.
What evidence suggests that this combined gastric mucosal ablation with endoscopic sleeve gastroplasty is effective for weight loss?
This trial will evaluate the combined gastric mucosal ablation with endoscopic sleeve gastroplasty procedure. Studies have shown that combining these two procedures can be effective for weight loss. Research indicates that this combined approach can lead to more significant weight loss compared to using endoscopic sleeve gastroplasty alone. Specifically, one study found that endoscopic sleeve gastroplasty alone resulted in about 16.6% total weight loss within a year, along with improvements in conditions like high blood pressure and type 2 diabetes. Additionally, endoscopic gastric fundal mucosal ablation has helped adults with obesity lose weight. Initial findings suggest that using these methods together might enhance weight loss results even more.26789
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo combined gastric mucosal ablation with endoscopic sleeve gastroplasty
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Combined gastric mucosal ablation with endoscopic sleeve gastroplasty
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All patients included in the multi-site, prospective registry will undergo the combined gastric mucosal ablation with endoscopic sleeve gastroplasty procedure, regardless of their participation in the research study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
True You Weight Loss
Lead Sponsor
Citations
Impact of endoscopic sleeve gastroplasty on weight loss ...
ESG can achieve total weight loss at one year of 16.6% of total weight with significant reduction of co-morbidities such as hypertension, T2DM, OSAS, ...
NCT06420700 | Ablation Registry (Combined Gastric ...
Preliminary data revealed enhanced clinical effectiveness for the single-stage approach when compared to traditional endoscopic sleeve gastroplasty while ...
May 2025
THE ADDITION OF GLP-1 RECEPTOR AGONIST THERAPY 12 MONTHS AFTER ENDOSCOPIC SLEEVE GASTROPLASTY ENHANCES THREE-YEAR WEIGHT LOSS OUTCOMES. Ali ...
Recent advances in bariatric endoscopy for obesity ...
Endoscopic sleeve gastroplasty promotes weight loss ... Endoscopic gastric fundal mucosal ablation induces weight loss in adults with obesity.
Ablation Registry (Combined Gastric Mucosal ...
The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone combined gastric ...
The Efficacy and Safety of Endoscopic Sleeve Gastroplasty as ...
These results suggest that ESG is effective for up to 5 years after the procedure, and its long-term durability is good for maintaining weight loss. COMPARISON ...
SAFETY AND EFFICACY OF ENDOSCOPIC REVISION ...
Endoscopic sleeve gastroplasty (ESG) has been demonstrated to be a safe, durable and effective procedure for management of obesity. In patients with weight ...
S1096 Early Safety and Efficacy of Endoscopic Sleeve...
ESG demonstrates comparable safety to SG with shorter procedure time and LOS. Clinicians may have been more inclined to readmit and intervene in ESG patients as ...
Ablation Registry (Combined Gastric Mucosal ...
The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone ...
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