Endoscopic Sleeve Gastroplasty Techniques for Obesity

Overseen By Michele B Ryan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: NSAIDs

Disqualifiers: Untreated H. pylori, Gastric ulcer, Malignant gastric diseases, Severe reflux, others

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

Compensation: Varies

Number of Visits: 7

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two techniques for a weight loss procedure called Endoscopic Sleeve Gastroplasty. It aims to determine if focusing on different parts of the stomach can lead to greater weight loss. Participants will join one of two groups: one with a "belt" pattern and the other with a "belt and suspenders" pattern for stomach sutures. Individuals who have struggled with obesity (BMI of 30 or higher) and are willing to attend follow-up visits might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future weight loss procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who require the use of Non-Steroidal Anti-inflammatory Drugs (NSAIDs).

What prior data suggests that these endoscopic sleeve gastroplasty techniques are safe for weight loss?

Research has shown that Endoscopic Sleeve Gastroplasty (ESG) is generally safe and well-tolerated. Studies indicate that the risk of serious side effects is much lower compared to traditional weight loss surgery. In one study, no patients experienced major medical problems after the procedure.

Both the "Belt" and "Belt and Suspenders" methods of ESG aim to aid weight loss by stitching parts of the stomach to make it smaller, helping individuals feel full sooner and eat less. In terms of safety, patients have reported positive outcomes, with very few complications. This makes ESG a promising option for managing obesity without major surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the endoscopic sleeve gastroplasty (ESG) techniques for obesity because they offer a less invasive alternative to traditional bariatric surgery. Unlike standard treatments like gastric bypass or sleeve gastrectomy, ESG is performed endoscopically, meaning it doesn’t require large incisions and typically results in a faster recovery time. The "Belt and Suspenders" configuration is particularly intriguing because it involves creating both proximal and distal gastric plications, potentially enhancing the effectiveness of the procedure in reducing stomach size and curbing appetite. These innovative approaches could lead to safer, more accessible weight loss options for people struggling with obesity.

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

Research has shown that Endoscopic Sleeve Gastroplasty (ESG) leads to significant weight loss. In this trial, participants will be assigned to one of two configurations. The "Belt" method typically results in a 13% to 20% reduction in total body weight within a year, and studies indicate that most people maintain much of their weight loss. The "Belt and Suspenders" method, another configuration tested in this trial, also effectively promotes weight loss and improves obesity-related conditions like diabetes and high blood pressure. Both methods are considered safe, with few serious side effects reported. Overall, ESG presents a promising option for effective weight loss. ^{1 2 4 5 6}

Who Is on the Research Team?

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals struggling with obesity who are looking to lose weight. Participants should be adults willing to undergo an endoscopic procedure, but those with certain gastrointestinal conditions or previous stomach surgeries may not qualify.

Inclusion Criteria

BMI ≥ 30 kg/m2

Capable of giving informed consent and available to return for follow-up visit

Exclusion Criteria

Substance abuse

I have a thyroid condition that affects my weight and it's not under control.

I have an untreated H. pylori infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic sleeve gastroplasty using the Endomina system with either 'belt' or 'belt and suspenders' configuration

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for weight loss and changes in obesity-related comorbidities

12 months

Regular visits at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Sleeve Gastroplasty - Belt
• Endoscopic Sleeve Gastroplasty - Belt and Suspenders

Trial Overview The study is testing two techniques of Endoscopic Sleeve Gastroplasty (ESG) using the Endomina system: one called 'Belt' and another 'Belt and Suspenders'. The goal is to see which method leads to more weight loss.

How Is the Trial Designed?

Group I: Belt and Suspenders Configuration Active Control 1 Intervention

Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).

Group II: Belt Configuration Active Control 1 Intervention

Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Endo Tools Therapeutics S.A.

Industry Sponsor

Trials

4

Recruited

1,200+

Published Research Related to This Trial

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) is a minimally invasive outpatient procedure that reduces stomach volume to aid in weight loss, but it carries risks of serious complications.

In a reported case, a patient experienced severe complications including ischemia, perforation, and peritonitis immediately after the procedure, highlighting the need for careful monitoring and management of potential risks associated with ESG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Sleeve Gastroplasty Leading to Gastric Ischemia and Perforation. Stolz, MP., Gibson, BH., Vassy, WM.[2023]

The Endoscopic Sleeve Gastroplasty using OverStitch was successfully performed on a male patient with a BMI of 35.17 kg/m2, demonstrating its feasibility and safety with no bleeding or complications during the procedure.

The procedure took only 50 minutes and resulted in mild abdominal pain, with the patient able to accept a liquid diet afterward, indicating a quick recovery and minimal discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ENDOSCOPIC SLEEVE GASTROPLASTY - MINIMALLY INVASIVE THERAPY FOR PRIMARY OBESITY TREATMENT. Galvão-Neto, MD., Grecco, E., Souza, TF., et al.[2022]

Citations

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

Outcomes of Endoscopic Sleeve Gastroplasty In summary, ESG consistently results in substantial weight loss—typically from 13% to 20% TBWL at 12 months—with additional benefits including ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06299644

Endoscopic Sleeve Gastroplasty Technique Comparison ... Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.6% - 4.9%.

3. oaepublish.com oaepublish.com/articles/mtod.2024.112

Endoscopic gastric remodeling procedures for obesity ... Weight recurrence after LSG can occur in 14% to 37% of patients over seven or more years. This long-term failure is often linked to sleeve ...

4. gi.org gi.org/journals-publications/ebgi/kolb_chiang_feb2023/

Endoscopic Sleeve Gastroplasty Is Effective for Patients ... Of the 60 patients who achieved their goal weight of >25% EWL at 1 year, 41 (68%) had sustained weight loss using the same definition at 2 years ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016510720300560

Endoscopic gastric body plication for the treatment of obesity The serious AE rate was 0%. At 6 months, patients experienced 15.0% ± 7.1% total weight loss (TWL). All patients achieved at least 5% TWL, and 8 patients (80 ...

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 ...