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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a procedure called Endoscopic Sleeve Gastroplasty (ESG) for treating obesity. ESG offers a less invasive option compared to traditional surgery by using an endoscopic device to reduce stomach size. It targets individuals with a body mass index (BMI) between 30 and 50 who have struggled to lose weight through diet and exercise alone. Those who have tried lifestyle changes but still find weight loss challenging might find this trial suitable. As an unphased trial, this study provides a unique opportunity to explore a promising weight-loss procedure that could benefit those seeking alternatives to traditional surgery.

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

Research has shown that Endoscopic Sleeve Gastroplasty (ESG) is generally safe for treating obesity. Studies have found that ESG is effective and manageable for patients, with positive results lasting up to 10 years after the procedure. Most individuals experience significant weight loss without serious side effects. This evidence suggests that ESG is a reliable option for individuals with obesity, whether mild or severe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Endoscopic Sleeve Gastroplasty (ESG) is unique because it offers a less invasive alternative to traditional surgical options like gastric bypass or sleeve gastrectomy for obesity. Unlike these standard surgeries, ESG uses an endoscopic approach with the Apollo OverStitch device to reduce stomach size, which means no external incisions and potentially quicker recovery times. Researchers are excited about ESG because it combines the benefits of significant weight loss with lower risks and complications, making it an appealing option for patients who may not qualify for or want conventional surgery.

What evidence suggests that endoscopic sleeve gastroplasty is effective for obesity?

Research shows that endoscopic sleeve gastroplasty (ESG), the procedure under study in this trial, helps people with obesity lose weight. Studies have found that ESG can lead to a total body weight loss of 13% to 20% within a year. This procedure is less invasive than surgery and can improve health issues related to obesity, such as diabetes and high blood pressure. Long-term evidence suggests that ESG remains effective for up to ten years. With a low complication rate of about 2%, ESG offers a safe option for managing obesity. ^{1 2 3 6 7}

Who Is on the Research Team?

Thomas R McCarty, MD, MPH

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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 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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12566468/

Outcomes of Endoscopic Sleeve Gastroplasty ESG has demonstrated effectiveness in achieving weight loss and improving obesity-related comorbidities while maintaining a favorable safety ...

2. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s2063_ten_year_outcomes_of_endoscopic_sleeve.2064.aspx

S2063 Ten-Year Outcomes of Endoscopic Sleeve ... The primary outcome was weight loss at 10 years after the procedure reported as percent total body weight loss (%TBWL). The safety and durability of ESG were ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X25002252

Transforming obesity care: the impact of endoscopic sleeve ... Our findings demonstrate that ESG is a highly effective, minimally invasive intervention for obesity, leading to significant weight loss and improvements in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06339320

Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of ... This study aims to perform ESG for patients with obesity, defined as a BMI 30-50 kg/m2. Additionally, data collection of relevant weight-related and metabolic ...

5. giejournal.org giejournal.org/article/S0016-5107(23)02864-X/fulltext

Weight regain after endoscopic sleeve gastroplasty Subsequent prospective studies have shown a total body weight loss (TBWL) at 12 months after ESG ranging from 13% to 20% and an adverse events ratio of 2%. A 5- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7939770/

The Efficacy and Safety of Endoscopic Sleeve Gastroplasty as ... These results suggest that ESG is a safe and effective option for patients with mild to moderate obesity as well as those with severe. Most previous studies ...

7. 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 the ...