A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Recruiting · Rochester, Minnesota
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
This study is testing whether an endoscopic sleeve procedure (ESG) can help people with obesity lose weight safely and effectively. It is for people with ulcerative colitis (UC) who are planning to have (or have already had) colon surgery and eventual IPAA. The study also checks whether participants can follow diet and visit schedules.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Have obesity based on BMI between 30 and 50 for at least 6 months
- •Have ulcerative colitis (UC) and are planning to have colectomy for an eventual 3-stage ileal pouch anal anastomosis (IPAA)
- •Can follow the diet and behavior changes needed for ESG
- •Can attend all study visits
- •Can agree to the informed consent process
🚫 You may not be able to join if…
- •Have had prior gastric/bariatric surgery or other changes to the upper GI tract that would prevent safe ESG
- •Have a current or recent (within last 6 months) stomach or duodenal ulceration
- •Have esophageal or gastric varices
- •Have significant problems with how the esophagus or stomach move (motility disorder)
- •If female: are pregnant or nursing, or plan pregnancy within the next year
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓A BMI around 30 or higher
- ✓Have Type 2 diabetes or Fatty liver disease (NASH/MASH)
- !Not for people who are pregnant or breastfeeding
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
The study team can share what safety testing has been done so far.
What you need to know before you apply
What is this study testing?+
This study is testing whether an endoscopic sleeve procedure (ESG) can help people with obesity lose weight safely and effectively. It is for people with ulcerative colitis (UC) who are planning to have (or have already had) colon surgery and eventual IPAA. The study also checks whether participants can follow diet and visit schedules.
Is it safe? Who makes sure of that?+
This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT05739162 · Locations: Minnesota