Endoscopic Sleeve Gastroplasty for Obesity

Recruiting in Palo Alto (17 mi)

Overseen by Amanda M Johnson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

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

Disqualifiers: Gastric surgery, Ulcers, Varices, others

No Placebo Group

Approved in 2 Jurisdictions

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Minnesota Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

References

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

Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope. [2022] Less invasive endoscopic bariatric procedures are under development for the management of class I of obesity. The purpose of our study is to evaluate the safety of endoscopic sleeve gastroplasty (ESG) using the new suturing device OverStitch Sx™.

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

Efficacy and feasibility of OverStitch suturing of leaks in the upper gastrointestinal tract. [2021] Management of upper gastrointestinal leaks is challenging. A new potential treatment option for this complication is endoscopic suturing with the OverStitch system (Apollo Endosurgery, Texas, USA), which is today mainly used for endoscopic sleeve gastroplasty. The aim of this study was to analyze the efficacy and feasibility of this new treatment option in patients with leaks in the upper gastrointestinal tract.

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

ENDOSCOPIC SLEEVE GASTROPLASTY - MINIMALLY INVASIVE THERAPY FOR PRIMARY OBESITY TREATMENT. [2022] Less invasive and complex procedures have been developed to treat obesity. The successful use of Endoscopic Sleeve Gastroplasty using OverStitch(r) (Apollo Endosurgery, Austin, Texas, USA) has been reported in the literature.

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

Endoscopic management of common patologies with a new suturing system. [2017] Overstitch endoscopic suturing system (Apollo Endosurgery. Austin, Texas) was created for NOTES procedures.As it demonstrated to be feasible, secure and effective in this field, further studies have evaluated its use in common gastrointestinal disorders in which current therapeutic tools, endoscopic or not, are not efficient or safe enough. Published results are promising. We present our initial experience with this system in the management of pathologies we usually face in our clinical practice.

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

Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management. [2017] Many obese patients cannot lose weight or reject conventional obesity management. Endoscopic sleeve gastroplasty (the Apollo method) is a pioneering coadjuvant, interventionist technique for the integral management of obesity.

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

Endoscopic suturing for GI applications: initial results from a prospective multicenter European registry. [2022] OverStitch devices (OverStitch and OverStitch Sx; Apollo Endosurgery, Inc, Austin, Tex, USA) are used for a wide range of applications. A European registry was created to prospectively collect technical and clinical data regarding both systems to provide procedural outcomes and to find correlation between procedural characteristics and outcomes. This study shows the initial results of the first 3 years of the registry.

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

Endoscopic Sleeve Gastroplasty Leading to Gastric Ischemia and Perforation. [2023] Endoscopic sleeve gastroplasty (ESG) is performed by using endoscopic suctioning to reduce the volume of the stomach by plicating the greater curvature with an endoscopic suturing device or stapler. This allows for the endoscopist to perform an elective outpatient weight loss procedure. We will describe a single case of post-procedure day zero complication involving ESG resulting in ischemia, perforation, and peritonitis; what was discovered intra-operatively; and our operative management.