Endobariatric Procedure for Obesity

Overseen By Liliana Bancila

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Esophageal stenosis, Malignancy, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day for procedure, ongoing for behavioral intervention

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulation or anti-platelet medications (like ASA or Plavix) for 1 week before and 2 weeks after each endoscopy. For other medications, the protocol does not specify.

What data supports the effectiveness of the treatment Endobariatric Procedure for Obesity?

Research shows that Endoscopic Sleeve Gastroplasty (ESG), a type of endobariatric procedure, is effective for weight loss and improving obesity-related health issues. It is a minimally invasive method that reshapes the stomach and has been found to be safer and more effective than some drug treatments for obesity. ^{1 2 3 4 5}

Is the endoscopic sleeve gastroplasty (ESG) procedure safe for humans?

Endoscopic sleeve gastroplasty (ESG) is generally considered a safe procedure for weight loss, with studies showing it to be minimally invasive and effective for obesity management. ^{3 6 7 8 9}

How is the Endobariatric procedure different from other obesity treatments?

The Endobariatric procedure, specifically Endoscopic Sleeve Gastroplasty (ESG), is unique because it is a minimally invasive treatment that reduces stomach size using sutures, unlike traditional surgeries that require incisions. This approach offers a less invasive option with fewer complications compared to more invasive bariatric surgeries like laparoscopic sleeve gastrectomy. ^{1 2 3 10 11}

What is the purpose of this trial?

This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\]) as clinically indicated, and subsequent follow up clinic visits for up to one year.

Research Team

Kenneth Park, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for adults over 18 with obesity, defined as a BMI >30 without other health issues or >27 with them. It's open to those who haven't had the weight loss they expected from previous bariatric surgery and are willing to follow the study plan. People can't join if they have esophageal problems, cancer in that area, severe health issues affecting life expectancy, uncontrolled bleeding disorders, or are pregnant.

Inclusion Criteria

I am willing and able to follow the study's requirements.

I had weight loss surgery but didn't lose enough weight or gained it back.

My BMI is over 27 and I have health issues related to obesity.

Exclusion Criteria

My cancer is in the esophagus, stomach, or upper small intestine.

Patient refuses or is unable to provide written informed consent

I have had surgery or an endoscopic procedure to treat acid reflux.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic bariatric therapy (EBT) procedures such as endoscopic sleeve gastroplasty (ESG) or transoral outlet reduction (TORe), along with behavioral interventions including diet therapy, exercise therapy, and behavior modification.

1 day for procedure, ongoing for behavioral intervention

1 visit (in-person) for procedure, ongoing visits for behavioral intervention

Follow-up

Participants are monitored for changes in body weight and hormonal profiles at 1 month, 3 months, 6 months, and 1 year post-procedure.

12 months

4 visits (in-person) at 1 month, 3 months, 6 months, and 1 year

Treatment Details

Interventions

• Endobariatric procedure

Trial Overview The study tests endoscopic bariatric procedures (ESG or TORe) on patients needing weight loss treatment. Over one year, participants will undergo these procedures and attend follow-up visits to assess benefits and monitor progress.

Participant Groups

Group I: Endoscopic sleeve gastroplasty/Transoral outlet reduction Experimental Treatment 1 Intervention

Endobariatric procedure is already approved in United States, European Union for the following indications:

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

• Weight loss for obesity
• Reduction of weight-related illnesses such as high blood pressure, diabetes, fatty liver disease, sleep apnea, and heart disease

Approved in European Union as Endoscopic Sleeve Gastroplasty (ESG) for:

• Weight loss for obesity
• Reduction of weight-related illnesses such as high blood pressure, diabetes, fatty liver disease, sleep apnea, and heart disease

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

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 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 a safe and effective weight loss procedure, with no reported procedure-related mortality among 2170 patients studied.

Patients experienced significant weight loss over time, with an average total weight loss of 15.3% at 6 months and 16.8% at 18 months, indicating its efficacy as a primary obesity therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Endoscopic Sleeve Gastroplasty at Mid Term in the Management of Overweight and Obese Patients: a Systematic Review and Meta-Analysis. de Miranda Neto, AA., de Moura, DTH., Ribeiro, IB., et al.[2021]

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) 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 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 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) led to significant weight loss and improved glycemic control over a 24-month follow-up in 20 patients, with the most notable improvements occurring six months post-procedure.

Unlike traditional surgical methods, ESG did not result in deficiencies in essential vitamins, indicating a safer profile while effectively altering glucose metabolism and positively affecting body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional consequences of endoluminal gastroplasty in the treatment of morbidly obese patients. Svagera, Z., Machytka, E., Machackova, J., et al.[2022]

Endoscopic sleeve gastroplasty (ESG) is an effective minimally invasive treatment for obesity, showing significant weight loss over 24 months, with a mean total weight loss of 20.01% and excess weight loss of 60.40%.

The procedure has a favorable safety profile, with a low incidence of serious adverse events at 2.26%, and no reported mortality, indicating it is a safe option for patients seeking bariatric therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Singh, S., Hourneaux de Moura, DT., Khan, A., et al.[2021]

Endoscopic sleeve gastroplasty (ESG) was successfully performed on 10 patients in a Norwegian center, demonstrating its feasibility as a less invasive weight loss procedure compared to traditional bariatric surgery.

The procedure resulted in a mean total body weight loss of 12.2% at 26 weeks and 9.1% at 52 weeks, with acceptable safety, although one patient experienced a minor complication that was managed without further issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway. Tønnesen, CJ., Hjelmesæth, J., Aabakken, L., et al.[2023]

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

Endoscopic sleeve gastroplasty as an early tool against obesity: a multicenter international study on an overweight population. [2023]

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

Brazilian Consensus on Endoscopic Sleeve Gastroplasty. [2021]

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

Efficacy and Safety of Endoscopic Sleeve Gastroplasty at Mid Term in the Management of Overweight and Obese Patients: a Systematic Review and Meta-Analysis. [2021]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. 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]

8. Denmark pubmed.ncbi.nlm.nih.gov

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

9. Czech Republic pubmed.ncbi.nlm.nih.gov

Nutritional consequences of endoluminal gastroplasty in the treatment of morbidly obese patients. [2022]

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

Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway. [2023]