Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

Inclusion Criteria:

- Male or female, aged ≥21 and ≤70 years

- Willing, able, and mentally competent to provide written informed consent

- Obese patients with a BMI ≥35 kg/m2

- Weight ≤400 lb

- 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

- Suitable for protocol therapy, as determined by the interventional radiology investigator

- Adequate hematologic (neutrophils>1.5x109/L, platelets>70x109/L, INR<1.5), hepatic (bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated GFR>60mL/min. 1.73m2) function

- For females of reproductive potential: agreement to use of highly effective contraception

- for duration of study participation

- Patients who have failed conservative weight loss therapies such as supervised low calorie diets combined with behavior therapy and exercise

- Live or work within 65 miles of the enrolling institution in case a catastrophic post embolization event occurs

Exclusion Criteria:

- hemoglobin A1c greater than 8%

- Patients who are currently taking either Insulin or sulfonylurea (medication changes are allowed)

- Prior history of gastric, pancreatic, hepatic, and/or splenic surgery

- Prior radiation therapy to the upper abdomen

- Prior embolization to the stomach, spleen, or liver

- Cirrhosis

- Known portal venous hypertension

- Active peptic ulcer disease

- Significant risk factors for peptic ulcer disease, including daily NSAID use

- Large hiatal hernia, defined as >5 cm in size

- Active H. Pylori infection

- Known aortic pathology, such as aneurysm or dissection

- Renal insufficiency, as evidenced by an estimated glomerular filtration rate of <60 mL/min

- Major comorbidity, such as active cancer, significant cardiovascular disease, or peripheral arterial disease

- Pregnancy

- Pre-existing chronic abdominal pain

- Positive stool occult blood study

- GI bleeding or bleeding diathesis within 5 years

- Weight loss (intentional or unintentional) of more than or equal to 5% of body weight in the 6 months prior to randomization

- A weight loss greater than 6lb during the weight management run- in

- Endoscopic findings that would preclude bariatric embolization (at the discretion of the study team)

- History of gastric motility disorders or an abnormal nuclear gastric motility examination (to be performed in diabetic subjects only)

- American Society of Anesthesiologists Class 4 or 5 (very high risk surgical candidates: class 4=incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study - this exclusion criterion exists, because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects

- Inflammatory bowel disease

- Autoimmune disease or HIV+

- History of allergy to iodinated contrast media

- Failure to comply with pre-procedure weight management "run-in", or other pre-procedural visits (specifically, participants must complete 80% of weight management and Lose It! Food tracking, and 100% of one-time visits, i.e. MRI, CTA, endoscopy)

- Applicability of any contraindication regarding patient's vasculature as per Instruction for Use

- Inability to have an MRI scan (i.e., metal implants or claustrophobia)

- Smokers/vape users/tobacco use

- Active or new-onset endocrine disorders (stable disease acceptable)

- Other unforeseen conditions that may make patients unsuitable for the procedure (study team discretion)

Exclusion Criteria (Psychiatric):

- As determined by clinical judgment based on Clinical Interview, psychological/behavioral measures, medical records, previous mental health records/other collateral information (as available) and consistent with DSM -5 criteria:

- Diagnosis of severe mental illness (i.e., chronic psychotic spectrum disorders, clinically significant mood disorders) AND/OR one or more of the following:

- Evidence of active relapse or active impairing symptoms (e.g., suicidal ideation, audio or visual hallucinations, paranoia, thought disturbance, severe impairment)

- Evidence of minimal supports or limited adherence to ongoing mental health care

- Failure to provide comprehensive aftercare plan that includes emergency plan for addressing future mental health relapse

- History of treatment refractory mental illness/recurrent relapse (multiple suicide attempts or inpatient psychiatric hospitalizations in the past 5 years)

- Within past 3 years: Inpatient psychiatric hospitalization

- Within past 5 years: Suicide attempt

- Declining to provide mental health records, a letter of support from mental health professionals, or consent for verbal consultation with mental health professionals when determined to be essential to evaluation.

- Cognitive impairment, if judged to have

- Limited capacity to make informed decision about procedure and inability to verbalize an understanding of the surgical procedure, risks and benefits.

- Inability to demonstrate an understanding of the permanency of lifestyle change required

- History of Anorexia or History of/Active Bulimia: If determined to be of low enough severity not to be a clear contraindication, minimum of 5 years abstinence from bulimia, current moderate to severe binge eating or night eating syndrome

- Active or History of Substance Abuse with less than 5 years of abstinence

- Current use of anti-tricyclic anti-depressants or steroids, psychiatric medications associated with weight gain.