Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES) (BAE2)

Johns Hopkins University

Status: Completed

Conditions: Weight Loss; Obesity; Morbid Obesity

Treatments: Device: Bariatric Embolization of Arteries with imaging visible Embolics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04197336

IRB00143169

Details and patient eligibility

About

The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.

Full description

The BEATLES study is an investigator-initiated, prospective, double-blinded, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity-related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.

Enrollment: 10 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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, international normalized ratio (INR<1.5), hepatic (bilirubin≤2.0mg/dL, albumin≥2.5g/L), and renal (estimated glomerular filtration rate (GFR)>60milliliter mL/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 milliliter(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
• Use of anti-obesity medications in the 12 months prior to screening
• 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, computed tomography angiography (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 diagnostic and statistical manual of mental disorders (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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention

Experimental group

Description:

There will be 10 pilot patients (See Statistical Analysis below for sample size calculations) for a total of 59 participants. Participants will be followed with study outcomes assessed for a period of 12 months. The duration of the study will be approximately three years.

Treatment:

Device: Bariatric Embolization of Arteries with imaging visible Embolics