NCT05739162

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 22 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA.

Conditions

• Obesity
• Ulcerative Colitis

Interventions

Type	Name	Description
DEVICE	Apollo Endoscopic Suture System	Endoscopic Sleeve Gastroplasty (ESG), and endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 70-80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
BEHAVIORAL	Lifestyle Intervention	Low-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed.

Timeline

• Start date: 2023-09-20
• Primary completion: 2026-06-01
• Completion: 2027-01-01
• First posted: 2023-02-22
• Last updated: 2025-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study