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Endoscopic Sleeve Gastroplasty

Endoscopic Sleeve Gastroplasty for Obesity

N/A
Recruiting
Led By Amanda M Johnson, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year following procedure
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the procedure site, digestive issues like nausea or vomiting, risks associated with endoscopy such as bleeding or infection, and possible nutritional deficiencies due to altered food intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year following procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of subjects with serious adverse events
Percent total body weight loss
Secondary study objectives
Change gastrointestinal symptom rating scale (GSRS)
Durable weight loss
Modified pouchitis disease activity index (mPDAI)
+2 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle Intervention
2001
Completed Phase 3
~8370

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Endoscopic Sleeve Gastroplasty (ESG) is a minimally invasive procedure that reduces the size of the stomach using an endoscopic suturing device, which limits food intake and promotes early satiety. This mechanism is similar to that of sleeve gastrectomy (SG), where a portion of the stomach is surgically removed to create a smaller, sleeve-shaped stomach. Roux-en-Y gastric bypass (RYGB) involves creating a small stomach pouch and rerouting the small intestine to this pouch, which reduces food intake and nutrient absorption. These treatments are crucial for obesity patients as they provide significant and sustained weight loss, improve metabolic conditions like type 2 diabetes, and reduce obesity-related comorbidities, thereby enhancing overall health and quality of life.
[Efficacy and future of endoscopic bariatric surgery in the treatment of obesity and metabolic diseases].

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,315 Previous Clinical Trials
2,954,402 Total Patients Enrolled
87 Trials studying Obesity
9,125 Patients Enrolled for Obesity
Amanda M Johnson, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials

Media Library

Apollo Endoscopic Suture System (Endoscopic Sleeve Gastroplasty) Clinical Trial Eligibility Overview. Trial Name: NCT05739162 — N/A
Obesity Research Study Groups: Endoscopic Sleeve Gastroplasty (ESG)
Obesity Clinical Trial 2023: Apollo Endoscopic Suture System Highlights & Side Effects. Trial Name: NCT05739162 — N/A
Apollo Endoscopic Suture System (Endoscopic Sleeve Gastroplasty) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05739162 — N/A
~6 spots leftby Jan 2026