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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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year following procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year following procedure
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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].
[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
3,357 Previous Clinical Trials
3,062,403 Total Patients Enrolled
87 Trials studying Obesity
9,122 Patients Enrolled for Obesity
Amanda M Johnson, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a large hiatal hernia with severe acid reflux.I am taking more than 5 mg of corticosteroids daily.I have not had stomach or weight-loss surgery that would affect undergoing ESG.I have a severe movement disorder in my esophagus or stomach.I have ulcerative colitis and am planning or have had a colectomy for a future 3-stage IPAA surgery.I have varicose veins in my esophagus or stomach.I use anti-inflammatory or blood-thinning medications daily without a doctor's advice.I am not pregnant, nursing, or planning to become pregnant in the next year.I am a woman who cannot become pregnant or will use birth control and have a negative pregnancy test.I do not have severe blood clotting issues, liver problems, or cirrhosis.I do not have severe liver, heart, or lung disease that makes endoscopy unsafe for me.I have a tumor in my stomach.I am not using and willing to avoid weight loss drugs or supplements.I have had a stomach or duodenal ulcer in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Endoscopic Sleeve Gastroplasty (ESG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.