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Endoscopic Sleeve Gastroplasty for Obesity
Study Summary
This trial researches the safety and effectiveness of a weight loss procedure (ESG) for obese patients with UC who need colectomy and eventual IPAA, compared to diet and lifestyle counseling.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Endoscopic Sleeve Gastroplasty (ESG)
- Group 2: Diet and Exercise
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Does this medical research require participants who are 25 years of age or older?
"Eligible candidates for this trial must be between the ages of 22 and 69 years old."
Does this trial have open enrollment opportunities?
"Clinicaltrials.gov confirms that this study is no longer recruiting patients, with the first post from March 1st 2023 and last update on February 13th 2023. Although currently inactive for enrollment, there are presently 1368 other trials actively accepting participants."
What positive results does the research team hope to achieve with this clinical trial?
"Over the course of 6 months, this trial will measure a number of outcomes including serious adverse events, delayed peri-operative complications due to IPAA and ileostomy takedown procedure, gastrointestinal symptom rating scale (GSRS) scores that quantify comfort associated with GI symptoms on a 7 point scale from no discomfort up to very severe discomfort, as well as Pouchitis Disease Activity Index(PDAI) which quantitates clinical symptoms and endoscopic/histological features into 3 separate six-point scores. A score higher than 7 is indicative of pouchitis."
May I enroll in this clinical research project?
"Currently, this medical trial is seeking 24 individuals aged between 22 and 69 who have been classified as obese. To qualify for the experiment, participants must possess a BMI of 30-50 kg/m2 from at least 6 months prior to ESG; they must be diagnosed with UC and plan on undergoing colectomy in order to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA); they need to abide by diet and behaviour modifications prescribed by the study; follow visit schedules; provide informed consent; if female, either postmenopausal or surgically sterile with negative serum Human Chorionic Gonadotropin"
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