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
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 69
Healthy Volunteers: f
View:

• BMI 30-50 kg/m2 for at least 6 months prior to ESG

• Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA)

• Willing to adhere to the diet and behavior modifications required for ESG

• Able to follow the visit schedule

• Able to provide informed consent

• If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline

Locations
United States
Minnesota
Mayo Clinic Minnesota
RECRUITING
Rochester
Contact Information
Primary
ESG with IPAA Study Team
DLRSTIPAAinfo@mayo.edu
507-538-8238
Backup
Abigail A Stromme
stromme.abigail@mayo.edu
507-538-8238
Time Frame
Start Date: 2023-09-20
Estimated Completion Date: 2026-01
Participants
Target number of participants: 12
Treatments
Experimental: Endoscopic Sleeve Gastroplasty (ESG)
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov