Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)
Condition: Obesity; Morbid Obesity; Weight Loss
MeSH terms: Obesity; Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      Obesity is defined as a body mass index (BMI) ≥30 kg/m2 and with a subclass of obesity known
      as morbid or severe obesity (BMI of ≥40 kg/m2). These are major issues in medicine for both
      participants and medical providers with >36% of the US population affected. Obesity is one of
      the biggest causes of preventable chronic diseases and healthcare costs in the USA. Obese
      adults spend 42% more on direct healthcare costs and morbidly obese adults overall have 81%
      higher healthcare costs than non-obese adults. Obesity is currently treated with dietary,
      pharmacological, and/or surgical approaches that are often unsuccessful or are associated
      with additional risks. As the incidence and prevalence of obesity and obesity-related
      diseases are steadily increasing, there is a growing need to detect the key risk factors
      involved in disease development and modify standard treatment procedures and protocols.

      The most successful long-term strategy continues to be bariatric and metabolic surgeries,
      such as sleeve gastrectomy and Roux-en-Y gastric bypass (RYGBP). The NIH recommends bariatric
      surgery for participants with a BMI of 40 kg/m2 or greater or a BMI of 35 kg/m2 or greater
      and obesity related comorbidities. These surgeries enable participants to lose between 50%
      and 75% of excess body weight. Despite this success, participants are apprehensive and do not
      undergo bariatric surgery with the biggest fear being the many complications that come with
      the procedure. Studies have shown that 57-77% of participants are not interested in bariatric
      surgery although the participants qualify.(16)

      With the concern of complications from bariatric surgery, interest in endoscopic bariatric
      techniques has increased over the years. The techniques have been shown to be efficacious,
      reversible, relatively safe, and cost effective. Further, these techniques offer a
      therapeutic window for some participants who may otherwise be unable to undergo bariatric
      surgery. The American Society for Gastrointestinal Endoscopy have approved endoscopic
      procedures, such as balloon therapy, for participants with BMI in the 30-40 kg/m2
      range.(17,18) However, the products used in these therapies also have several limitations
      primarily the inability to provide long term weight loss given the temporary nature of these
      balloons.(19) Common adverse events following intragastric balloon insertion include
      abdominal pain (33.7%), gastroesophageal reflux disease (18.3%), anorexia, and nausea (29%).
      Severe complications such as gastric ulcers (2%), small bowel obstruction (0.3%), perforation
      (0.1%), balloon migration (1.4%), and death (0.08%) are less common. Early balloon removal
      occurred in 9.1% of the study participants due to participant intolerance.(20)

      In a pilot study to assess safety and efficacy (BEAT Obesity), 20 morbidly obese participants
      with a BMI of ≥40 kg/m2 with no other comorbid conditions underwent bariatric embolization
      and were followed for 12 months. Participants were embolized with 300-500 µm Embospheres.
      None of the 20 participants in the BEAT Obesity trial (the largest prospective trial to date)
      had any major adverse events. Any gastric ulcers that occurred (40%) were asymptomatic and
      were completely healed by three months after the procedure.(21)

      There were many limitations of this study including the absence of a control cohort and
      non-compliance amongst study participants. A target population of participants with a BMI of
      40 kg/m2 and above was too high considering the bariatric embolization procedure is
      comparable to endoscopic bariatric therapies rather than bariatric surgery. BEAT Obesity
      excluded participants with comorbidities, such as those who suffer from diabetes, who may
      greatly benefit from this procedure and are often the target population for
      endoscopic/surgical bariatric therapies. A larger bead size of 300-500 µm was specifically
      chosen compared to preclinical data and prior clinical reports due to concerns of gastric
      ischemia and ulceration. However, smaller bead size produces greater weight loss and hormonal
      shifts.(22)

      Investigators hypothesize that transvascular bariatric embolization results in safe and
      effective weight loss in obese participants compared to control subjects.
    

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.
    

Intervention name(s): Bariatric Embolization of Arteries with imaging visible Embolics; Control Arm
Intervention type(s): Device; Other
Intervention description(s): The BEATLES study is an investigator-initiated, prospective, doubleblind, 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.; Participants randomized to the control arm will follow the same screening and pre-procedure assessment, and will also take the same pre-procedure medications. The procedural team instead will follow a prescribed simulated protocol that will mimic an actual embolization procedure.
Other intervention name(s): 100-200 µm radiopaque microspheres; Biocompatibles-001933
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, double-blinded, randomized, sham-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment