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Embolization Agent
Bariatric Embolization for Obesity (BAE2 Trial)
N/A
Waitlist Available
Led By Clifford Weiss, M.D.
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Summary
This trial investigates bariatric embolization, a minimally invasive procedure where tiny particles are injected into stomach blood vessels to reduce hunger. It targets obese individuals with a BMI of 40 kg/m2 or greater who may not be suitable for traditional bariatric surgery. By decreasing blood flow to the stomach, this method aims to help patients lose weight safely and effectively.
Eligible Conditions
- Obesity
- Weight Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of Bariatric Embolization procedure: Change in body weight
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Bariatric Embolization ProcedureActive Control1 Intervention
27 subjects will be enrolled in the bariatric embolization(BM) procedure arm. BM procedure will be performed under moderate sedation. Procedure will take 1.5 hr to 3 hr subject will be placed on the X-ray fluoroscopy table. Radial or femoral vascular access will be achieved using a small gauge needle, dilated over a guidewire to accommodate a 5 French vascular sheath. Standard catheters, 3 dimensional imaging will be acquired of the stomach, the arteries supplying the fundus arising off the celiac vessel. Microcatheter into the left gastric and/or gastroepiploic arteries supplying the fundus and small calibrated spheres will be infused until stasis of anterograde arterial flow is achieved, with particular care to avoid infusion of non-target arteries. The left gastric and/or gastroepiploic arteries will be embolized. Repeat 3 dimensional imaging: assess bead distribution and fundal coverage. Subject will be monitored in the recovery room and will be observed overnight.
Group II: Control ArmPlacebo Group1 Intervention
27 participants enrolled in the procedure arm. Participants randomized to the control arm will follow the same screening. Pre-procedure assessment will take the same pre-procedure meds. Procedure day, interventional radiologist will determine radial or groin access. After the participant and procedure area are prepped, participants will be under standard moderate sedation medications; all participants will receive lidocaine \& a skin nick to their groin or their wrist as determined by the operating physician. Participant will have a blind fold placed \& their hearing damped either with ear plugs or noise cancelling headphones. Participants randomized to the control arm will not receive other procedural intervention. Procedural team will follow a prescribed simulated protocol. Participants randomized to the control arm will be given under skin lidocaine and receive a skin nick on the wrist or groin.
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Who is running the clinical trial?
Biocompatibles UK LtdIndustry Sponsor
24 Previous Clinical Trials
2,519 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,874,719 Total Patients Enrolled
45 Trials studying Obesity
8,048 Patients Enrolled for Obesity
Clifford Weiss, M.D.Principal InvestigatorJohns Hopkins University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Bariatric Embolization Procedure
- Group 2: Control Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Obesity Patient Testimony for trial: Trial Name: NCT04197336 — N/A
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