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Endoscopic Sleeve Gastroplasty for Obesity

Ew
AA
Overseen ByAbigail A Stromme
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.12345

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.12346

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.12357

Research Team

AM

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.
See 3 more

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.
See 13 more

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

Treatment Details

Interventions

  • Apollo Endoscopic Suture System (Endoscopic Sleeve Gastroplasty)
  • Lifestyle Intervention (Behavioral Intervention)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Endoscopic Sleeve Gastroplasty (ESG)Experimental Treatment2 Interventions
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.

Find a Clinic Near You

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.
Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope.Manos, T., Costil, V., Karsenty, L., et al.[2022]
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.
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.
Endoscopic management of common patologies with a new suturing system.González-Panizo-Tamargo, F., Rojas-Sánchez, Á., Miranda-García, P., et al.[2017]

References

Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope. [2022]
Efficacy and feasibility of OverStitch suturing of leaks in the upper gastrointestinal tract. [2021]
ENDOSCOPIC SLEEVE GASTROPLASTY - MINIMALLY INVASIVE THERAPY FOR PRIMARY OBESITY TREATMENT. [2022]
Endoscopic management of common patologies with a new suturing system. [2017]
Endoscopic sleeve gastroplasty (the Apollo method): a new approach to obesity management. [2017]
Endoscopic suturing for GI applications: initial results from a prospective multicenter European registry. [2022]
Endoscopic Sleeve Gastroplasty Leading to Gastric Ischemia and Perforation. [2023]