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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an endoscopic procedure for weight loss to evaluate its effectiveness over a year. Known as an endobariatric procedure, it reshapes the stomach using a scope through the mouth, potentially aiding weight loss without traditional surgery. Individuals struggling with obesity (BMI over 30) or who have not succeeded with previous weight-loss surgeries might be suitable for this study. Participants must attend clinic visits for a year. As an unphased trial, this study provides a unique opportunity to explore a novel weight-loss method that could benefit those seeking alternatives to traditional surgery.

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 prior data suggests that these endobariatric procedures are safe for obesity?

Research shows that both endoscopic sleeve gastroplasty (ESG) and transoral outlet reduction (TORe) are generally safe. Studies have found that ESG is well-tolerated, with many patients successfully losing weight. In a review of 137 patients, ESG proved safe, with most losing a significant amount of weight within six months.

A larger study followed ESG over six years and confirmed its excellent safety and effectiveness for treating obesity. Another study with 193 patients reported an average weight loss of 15% one year after the procedure, with no major safety concerns.

While specific safety data for TORe isn't detailed here, the similarity of the procedures suggests that TORe might also be safe. Always consult a healthcare provider to discuss potential risks and benefits for your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endobariatric procedures for obesity because they offer a less invasive alternative to traditional weight-loss surgeries like gastric bypass and sleeve gastrectomy. One of the standout features is the use of endoscopic sleeve gastroplasty, which involves modifying the stomach's size and shape without the need for external incisions. This approach can potentially lead to shorter recovery times, fewer complications, and reduced healthcare costs. Additionally, methods like transoral outlet reduction target specific areas of the stomach, providing a customized treatment option that isn't available with more conventional surgeries.

What evidence suggests that endobariatric procedures are effective for obesity?

Research has shown that endoscopic sleeve gastroplasty (ESG), a procedure under study in this trial, can lead to significant weight loss. Studies indicate that patients typically lose between 12% to 20% of their body weight within a year after the procedure. Specifically, one study found that most patients lost about 10% of their total weight after 12 months. This procedure also results in fewer complications compared to traditional surgery. These findings suggest that ESG is an effective weight loss option for individuals with obesity. ^{3 4 6 7 8}

Who Is on the Research Team?

Kenneth Park, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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) 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) 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]

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) 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

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Endoscopic sleeve gastroplasty: a narrative review on ... With a sample of 137 patients, the authors concluded that the SG promotes better weight loss at 6 months (23.6% ± 7.6% vs. 17.1% ± 6.5%, P < 0.01) at a cost of ...

2. giejournal.org giejournal.org/issue/S0016-5107(25)X0005-5?pageStart=2

May 2025 THE ADDITION OF GLP-1 RECEPTOR AGONIST THERAPY 12 MONTHS AFTER ENDOSCOPIC SLEEVE GASTROPLASTY ENHANCES THREE-YEAR WEIGHT LOSS OUTCOMES. Ali ...

3. scfacs.org scfacs.org/wp-content/uploads/2022/07/Bermudez-Endoscopic-Sleeve-Gastroplasty.pdf

Endoscopic sleeve gastroplasty: a review of the data Endoscopic revision of the GJA is associated with significantly fewer total and serious AEs and similar long-term weight loss when compared with surgical ...

4. ddw.digitellinc.com ddw.digitellinc.com/p/s/endoscopic-sleeve-gastroplasty-with-anti-obesity-medications-analysis-of-combination-therapy-optimal-timing-and-agents-2505

ENDOSCOPIC SLEEVE GASTROPLASTY WITH ANTI ... Outcomes included percent total weight loss (%TWL) at 12 months, success rate (≥10% TWL at 12 months) and serious adverse event (SAE) rate. Results: 224 ...

5. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/endoscopic-sleeve-gastroplasty

Endoscopic Sleeve Gastroplasty People who had endoscopic sleeve gastroplasty lose approximately 12% to 20% of their body weight within one year. It is important to understand that although ...

6. giejournal.org giejournal.org/article/S0016-5107(23)02296-4/pdf

A 6-YEAR ANALYSIS (2016-2021) Background: Endoscopic sleeve gastroplasty (ESG) is an emerging endoscopic treat- ment for obesity with excellent preliminary safety and efficacy data. As ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN210045.pdf

DEN210045 decision summary - accessdata.fda.gov Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic procedure that involves the creation of plications in the stomach to reduce stomach volume ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356519308973

Efficacy and Safety of Endoscopic Sleeve Gastroplasty A recent multicenter international study on 193 patients reported a TBWL of 15% at 1 year after the procedure,10 and a recent meta-analysis of studies published ...