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Bariatric Embolization for Obesity (BAE2 Trial)
BAE2 Trial Summary
This trial found that transvascular bariatric embolization resulted in safe and effective weight loss in obese participants compared to control subjects.
- Obesity
- Weight Loss
BAE2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BAE2 Trial Design
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Who is running the clinical trial?
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- You are willing, able, and mentally competent to provide written informed consent.Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist is amendable to bariatric embolization, as assessed via 3D CT angiography.You have lost more than 6 pounds during the weight management period.You are a smoker, use vape products, or use tobacco.You have a hormone-related condition that is currently active or has recently developed. However, if your condition is stable, you may still be eligible to participate.You take nonsteroidal anti-inflammatory drugs (NSAIDs) every day, which can increase your chances of getting stomach ulcers.You have participated in the study for at least 6 months.You are living or working within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs.You are currently taking insulin or sulfonylurea medications. However, you can switch to different medications if needed.You have a big hernia in your diaphragm that is larger than 5 centimeters.You are a male or female, aged ≥21 and ≤70 years.You have failed conservative weight loss therapy and are 18 or older.You have a condition called portal venous hypertension.You currently have a stomach ulcer that is causing problems.You are of reproductive potential.You have received radiation therapy in the upper abdomen area before.You have a known problem with your aorta, like an aneurysm or tear.You have long-lasting stomach pain before joining the study.You have experienced significant gastrointestinal bleeding or have a tendency to bleed excessively within the past 5 years.You have taken medications for weight loss in the past year.You have an autoimmune disease or are HIV positive.You have had an allergic reaction to a type of dye used in medical imaging tests.There may be other unexpected conditions that the study team considers unsuitable for participation.You have had a procedure called embolization done on your stomach, spleen, or liver in the past.You have lost 5% or more of your body weight in the past 6 months, whether on purpose or by accident.The study team will decide if the findings from an endoscopy procedure prevent you from participating in the bariatric embolization study.
- Group 1: Bariatric Embolization Procedure
- Group 2: Control Arm
- 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
To whom is this research opportunity available?
"This medical trial seeks out 59 individuals aged between 21 and 70 with obesity, as measured by a BMI of 35 or higher. Criteria for enrolment include: A maximum weight of 400 lbs; living/working within 65 miles in case of an emergency; amendable vascular anatomy (including celiac, hepatic and gastric arteries) assessed via 3D CT angiography; and failure to lose weight through conservative treatments such as supervised diets combined with behavior therapy and exercise."
How many participants are currently being monitored in this research project?
"Affirmative. As seen on clinicaltrials.gov, this trial is actively searching for 59 volunteers from 1 location. The trial was first initiated on January 10th 2020 and has recently been updated as of January 21st 2022."
Is there still availability for people to join this research trial?
"This trial, first advertised on the 10th of January 2020 and most recently updated 21st of January 2022 according to clinicaltrials.gov, is actively seeking patients."
Can individuals below the age of 45 participate in this medical study?
"This clinical investigation necessitates that participants are no younger than 21 and not more advanced in years than 70."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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