Endoscopic Sleeve Gastroplasty for Obesity

Overseen By Abigail A Stromme

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids, NSAIDs, Anticoagulants, others

Disqualifiers: Gastric surgery, Ulcers, Varices, 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: Unknown

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is studying the safety and effectiveness of a procedure called Endoscopic Sleeve Gastroplasty (ESG) for weight loss in obese patients with ulcerative colitis who are having their colon removed. ESG makes the stomach smaller, helping patients eat less and lose weight. The study compares ESG to diet and lifestyle counseling.

Will I have to stop taking my current medications?

The trial requires that you avoid using weight loss medications, supplements, or herbal preparations. If you are using corticosteroids at a dose greater than 5 mg daily or anti-inflammatory agents like non-steroidal medications or anticoagulants, you must be under medical supervision. The protocol does not specify other medication restrictions.

What data supports the effectiveness of the treatment Endoscopic Sleeve Gastroplasty for Obesity?

Research shows that Endoscopic Sleeve Gastroplasty (ESG) using the OverStitch system is a successful and less invasive method for treating obesity, with promising results in weight management. It has been reported as effective in managing obesity when traditional methods are not suitable. ^{1 2 3 4 5}

Is Endoscopic Sleeve Gastroplasty safe for humans?

Endoscopic Sleeve Gastroplasty (ESG) using the OverStitch system has been reported as a less invasive and generally safe procedure for managing obesity, with studies showing promising results in terms of safety and effectiveness. ^{1 2 3 4 6}

How is the Endoscopic Sleeve Gastroplasty treatment different from other obesity treatments?

Endoscopic Sleeve Gastroplasty (ESG) is unique because it is a minimally invasive procedure that uses an endoscopic suturing device to reduce the size of the stomach, helping patients lose weight without the need for traditional surgery. This makes it a less complex and potentially safer option for those who cannot undergo or prefer to avoid conventional obesity surgeries. ^{1 2 3 5 7}

Research Team

Amanda M Johnson, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for obese ulcerative colitis patients planning or having had colectomy, aiming for ileal pouch anal anastomosis. They must have a BMI between 30-50 kg/m2, be willing to follow diet and lifestyle changes, attend scheduled visits, and provide consent. Women should use birth control if of childbearing potential.

Inclusion Criteria

Willing to adhere to the diet and behavior modifications required for ESG

I have ulcerative colitis and am planning or have had a colectomy for a future 3-stage IPAA surgery.

I am a woman who cannot become pregnant or will use birth control and have a negative pregnancy test.

Exclusion Criteria

Alcohol or drug addiction

I have a large hiatal hernia with severe acid reflux.

I am taking more than 5 mg of corticosteroids daily.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Endoscopic Sleeve Gastroplasty (ESG) Procedure

Participants undergo Endoscopic Sleeve Gastroplasty (ESG) followed by a 6-week transitional diet

6 weeks

Lifestyle Intervention

Participants start a lifestyle intervention following the transitional diet

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of peri-operative complications and weight loss

12 months

Treatment Details

Interventions

• Apollo Endoscopic Suture System
• Lifestyle Intervention

Trial Overview The study tests the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) versus only diet and lifestyle counseling in weight loss among obese ulcerative colitis patients before or after colectomy surgery.

Participant Groups

Group I: Endoscopic Sleeve Gastroplasty (ESG) Experimental Treatment 2 Interventions

Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.

Apollo Endoscopic Suture System is already approved in United States, European Union for the following indications:

Approved in United States as Apollo ESG / OverStitch NXT for:

• Endoscopic Sleeve Gastroplasty (ESG)
• Transoral Outlet Reduction (TORe)

Approved in European Union as Apollo ESG / OverStitch NXT for:

• Endoscopic Sleeve Gastroplasty (ESG)
• Transoral Outlet Reduction (TORe)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Endoscopic sleeve gastroplasty (ESG) using the OverStitch Sx™ device was found to be a safe procedure, with only 1.04% of patients experiencing post-procedural complications and no major intra-procedure adverse events reported among 191 patients.

The procedure resulted in significant weight loss, with an average total weight loss of 22.4% at 6 months and 18.7% at 12 months, indicating its efficacy as a minimally invasive treatment for primary obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope. Manos, T., Costil, V., Karsenty, L., et al.[2022]

Endoscopic suturing with the OverStitch system was successfully performed on 13 patients with upper gastrointestinal leaks, achieving a 100% interventional success rate in closing the leaks.

The technique was found to be safe, with no serious complications reported, and it is particularly effective for patients with large leaks who have not undergone prior treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and feasibility of OverStitch suturing of leaks in the upper gastrointestinal tract. Chon, SH., Toex, U., Plum, PS., et al.[2021]

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]

The Overstitch endoscopic suturing system was successfully used in 5 patients over 6 months for two main applications: stent fixation to prevent migration and outlet reduction after gastric bypass, achieving technical success in all cases.

All patients experienced clinical recovery, with significant weight loss in those who underwent outlet reduction, demonstrating the system's safety and effectiveness in managing gastrointestinal disorders where other treatments may not be sufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic management of common patologies with a new suturing system. González-Panizo-Tamargo, F., Rojas-Sánchez, Á., Miranda-García, P., et al.[2017]

Endoscopic sleeve gastroplasty using the Apollo method is a safe and effective weight loss intervention, with no major complications reported in a study of 55 patients over 6 months.

Patients experienced an average weight loss of 18.9 kg and a 55.3% reduction in excess weight, demonstrating significant efficacy when combined with dietary and psycho-behavioral support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management. López-Nava Breviere, G., Bautista-Castaño, I., Fernández-Corbelle, JP., et al.[2017]

The OverStitch devices demonstrated a 100% technical feasibility rate and a high technical success rate of 99.3% in endoscopic suturing across 137 patients, indicating their reliability for various applications.

The overall clinical success rate was 89%, with particularly high success in treating mucosal defects (100%) and perforations (94.7%), suggesting that OverStitch technology is effective for resolving clinical issues, especially for fistulas smaller than 1 cm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic suturing for GI applications: initial results from a prospective multicenter European registry. Maselli, R., Palma, R., Traina, M., et al.[2022]

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

Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and feasibility of OverStitch suturing of leaks in the upper gastrointestinal tract. [2021]

3. Brazil pubmed.ncbi.nlm.nih.gov

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

4. Spain pubmed.ncbi.nlm.nih.gov

Endoscopic management of common patologies with a new suturing system. [2017]

5. Spain pubmed.ncbi.nlm.nih.gov

Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management. [2017]

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

Endoscopic suturing for GI applications: initial results from a prospective multicenter European registry. [2022]

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

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