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

10 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Endoscopic Sleeve Gastroplasty for obesity?

Endoscopic Sleeve Gastroplasty (ESG) is shown to be a safe and effective treatment for obesity, with studies highlighting its ability to reduce stomach size using sutures, leading to significant weight loss. It is a less invasive option compared to traditional bariatric surgery, with good outcomes and minimal complications. ^{1 2 3 4 5}

Is endoscopic sleeve gastroplasty safe for humans?

Endoscopic sleeve gastroplasty is generally considered safe with minimal complications, although rare serious complications can occur that may require emergency surgery. ^{1 3 5 6 7}

How is the Endoscopic Sleeve Gastroplasty - Belt and Suspenders treatment different from other obesity treatments?

Endoscopic Sleeve Gastroplasty (ESG) is a unique, minimally invasive treatment for obesity that involves reducing the stomach's size using an endoscopic suturing device, which is less invasive than traditional surgery. The 'Belt and Suspenders' technique may refer to a modification that aims to improve the distribution of suture tension, potentially enhancing the procedure's safety and effectiveness. ^{1 2 3 4 8}

What is the purpose of this trial?

The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

Research Team

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

I have an untreated H. pylori infection.

Substance abuse

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Modified endoscopic gastroplasty for the treatment of obesity. [2019]

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

Endoscopic sleeve gastroplasty is feasible after failed modified primary obesity surgery endoluminal procedure. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

ENDOSCOPIC SLEEVE GASTROPLASTY - MINIMALLY INVASIVE THERAPY FOR PRIMARY OBESITY TREATMENT. [2022]

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

Endoscopic sleeve gastroplasty requiring emergent partial gastrectomy. [2020]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of endoscopic sleeve gastroplasty and laparoscopic sleeve gastrectomy with 12+ months of adjuvant multidisciplinary support. [2022]

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

Endoscopic Sleeve Gastroplasty Leading to Gastric Ischemia and Perforation. [2023]