Clinical trial NCT04197336: Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)
Official title: Bariatric Embolization of Arteries With Imaging Visible Embolics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Morbid Obesity
Weight Loss
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Biocompatibles UK Ltd
First posted: 2019-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body Weight as Assessed by BMI (kg/m^2)
timeFrame: 12 months
measure: Change in Body Weight (Pounds)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Clifford Weiss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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