Endoscopic Sleeve Gastroplasty for Obesity

Recruiting at 1 trial location

Overseen By Thomas R McCarty, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Pregnancy, Tobacco use, Gastric lesions, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on antiplatelet or anticoagulant therapy, it may need to be corrected before participating.

What data supports the effectiveness of the treatment Endoscopic Sleeve Gastroplasty (ESG) for obesity?

Research shows that Endoscopic Sleeve Gastroplasty (ESG) is a safe and effective treatment for obesity, leading to significant weight loss and improvement in obesity-related health issues. Studies have demonstrated that ESG reduces the size of the stomach without incisions, resulting in sustained weight loss and better outcomes compared to some other weight loss procedures. ^{1 2 3 4 5}

Is Endoscopic Sleeve Gastroplasty (ESG) safe for humans?

Endoscopic Sleeve Gastroplasty (ESG) is generally considered safe for humans, as studies have shown it to be a minimally invasive procedure with low risk and effective for weight loss. ^{2 4 6 7 8}

How is the treatment Endoscopic Sleeve Gastroplasty (ESG) unique for obesity?

Endoscopic Sleeve Gastroplasty (ESG) is unique because it is a minimally invasive, incisionless procedure that uses sutures to reduce the size of the stomach, promoting weight loss without the need for surgery. This makes it different from other treatments like laparoscopic sleeve gastrectomy, which involves surgical removal of part of the stomach. ^{1 2 4 5 9}

What is the purpose of this trial?

The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS).

Research Team

Thomas R McCarty, MD, MPH

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for individuals with obesity, having a BMI between 30 to 50 kg/m2, who haven't successfully lost weight through diet and exercise. It's not suitable for those with large hiatal hernias, severe blood clotting issues, recent tobacco use, active pregnancy, bleeding stomach lesions or cancers of the digestive tract.

Inclusion Criteria

Patients that have been unable able to lose weight, or maintain weight loss, through more conservative measures per the FDA approval for the Apollo ESG device. Measures may include traditional diet and exercise.

My BMI is between 30 and 50.

Exclusion Criteria

Hiatal hernia >5 cm

I have a severe blood clotting disorder that can't be treated.

Patients who are actively pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo the Endoscopic Sleeve Gastroplasty (ESG) procedure using the Apollo OverStitch endoscopic suturing device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the ESG procedure, with data collection on BMI and A1C at specified intervals

12 months

Follow-up visits at 4 weeks, 3 months, 6 months, and 12 months

Long-term Monitoring

Participants are monitored for treatment-related adverse events and procedural success over an extended period

10 years

Treatment Details

Interventions

• Endoscopic Sleeve Gastroplasty (ESG)

Trial Overview The study tests Endoscopic Sleeve Gastroplasty (ESG) using the Apollo OverStitch device. ESG is an FDA-approved procedure aimed at reducing stomach size non-surgically to treat obesity. The trial will be conducted at centers approved by MBSAQIP after IRB authorization.

Participant Groups

Group I: ESG Procedure Experimental Treatment 2 Interventions

Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.

Endoscopic Sleeve Gastroplasty (ESG) is already approved in United States for the following indications:

Approved in United States as Endoscopic Sleeve Gastroplasty (ESG) for:

• Obesity in patients with a body mass index (BMI) 30-50 kg/m2

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Findings from Research

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 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) 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 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 an effective and safe procedure for weight loss, achieving an average total weight loss of 16.3% at 12 months, which is significantly greater than that from intragastric balloon insertion and high-intensity diet therapy.

ESG has a lower rate of adverse events (5.2%) compared to laparoscopic sleeve gastrectomy (16.9%) and intragastric balloon placement (17%), making it a safer option for obesity treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and safety of endoscopic sleeve gastroplasty for treating obesity - a systematic review. Due-Petersson, R., Poulsen, IM., Hedbäck, N., et al.[2021]

Endoscopic sleeve gastroplasty (ESG) demonstrated significant weight loss efficacy, with an average total body weight loss of 16.09% and excess weight loss of 59.08% after 12 months, based on a review of 1542 patients from nine studies.

ESG is considered a safe procedure, with a low rate of severe adverse events (only 1%) and a higher incidence of mild adverse events (72%), suggesting it is a promising minimally invasive alternative to traditional bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. Li, P., Ma, B., Gong, S., et al.[2021]

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) can be reversed successfully within the first month without significant complications like fibrosis or scarring, indicating a favorable safety profile in the short term.

Despite most sutures dehiscing by 2 years, the procedure still resulted in a sustained reduction in gastric volume, suggesting that ESG can lead to lasting anatomical changes that promote weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing? Runge, TM., Yang, J., Fayad, L., et al.[2021]

References

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

Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? [2019]

2. 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]

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

Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. [2017]

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

Brazilian Consensus on Endoscopic Sleeve Gastroplasty. [2021]

5. 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]

6. Denmark pubmed.ncbi.nlm.nih.gov

Effect and safety of endoscopic sleeve gastroplasty for treating obesity - a systematic review. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. [2021]

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

Systematic Review of Innovation Reporting in Endoscopic Sleeve Gastroplasty. [2022]

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

Anatomical Configuration of the Stomach Post-Endoscopic Sleeve Gastroplasty (ESG)-What Are the Sutures Doing? [2021]