What side effects are associated with this type of intervention?

Common treatments for obesity, such as Endoscopic Sleeve Gastroplasty (ESG), laparoscopic sleeve gastrectomy, and Roux-en-Y gastric bypass, share several potential side effects. These can include gastrointestinal issues like nausea, vomiting, and diarrhea. There is also a risk of more serious complications such as gastrointestinal leaks, infections, and nutritional deficiencies due to reduced absorption of nutrients. Additionally, patients may experience surgical complications like bleeding and adverse reactions to anesthesia. Long-term side effects can include changes in bowel habits and the potential for weight regain if lifestyle changes are not maintained.

What prior FDA approvals exist?

The FDA has approved several treatments for obesity that involve minimally invasive procedures similar to Endoscopic Sleeve Gastroplasty (ESG). One notable example is the laparoscopic sleeve gastrectomy, which involves surgically removing a portion of the stomach to reduce its size and limit food intake. Another approved treatment is the laparoscopic Roux-en-Y gastric bypass, which not only reduces stomach size but also alters the digestive tract to limit calorie absorption. Additionally, the FDA has approved intragastric balloons, which are endoscopically placed in the stomach to occupy space and promote a feeling of fullness. These treatments share the common goal of reducing stomach volume to facilitate weight loss, similar to the mechanism of ESG.

What other types of research exist?

Promising, novel alternatives to Endoscopic Sleeve Gastroplasty (ESG) for obesity treatment in 2024 include: 1) Endoscopic Gastric Balloon: A temporary balloon is placed in the stomach to reduce its volume and promote a feeling of fullness. 2) Endoscopic Sleeve Gastroplasty with Suturing Devices: Advanced suturing techniques to create a sleeve-like effect without surgery. 3) Transoral Gastroplasty (TOGA): An endoscopic procedure that creates a restrictive pouch in the stomach. 4) Laparoscopic Mini-Gastric Bypass: A simpler, less invasive version of the traditional gastric bypass. 5) Endoscopic Duodenal-Jejunal Bypass Liner: A liner placed in the small intestine to prevent absorption of a portion of the food intake.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year following procedure

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

Number of early peri-operative complications

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

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.

Group II: Diet and ExerciseActive Control1 Intervention

Participants receive lifestyle intervention only for 24 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lifestyle Intervention

2001

Completed Phase 3

~8370

Do I qualify?Apply below to find out

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

3,298 Previous Clinical Trials

3,958,421 Total Patients Enrolled

86 Trials studying Obesity

9,011 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), Diet and Exercise

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

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