The Lowering Weight in Severe Obesity by Embolization of the Gastric Artery Trial (LOSEIT)

This is an interventional treatment trial for Obesity, Morbid focused on measuring Obesity, Embolization, Left Gastric Artery Read More

Inclusion Criteria:

• • BMI 35.0-50.0 kg/m2 at time of screening

  • Women of childbearing potential must agree to use at least one form of birth control (prescription hormonal contraceptives, diaphragm, IUD, condoms with or without spermicide, or voluntary abstinence) from time of study enrollment through study exit.
  • Willing and able to provide informed consent

Exclusion Criteria:

• • Previous bariatric, gastric pancreatic, hepatic, and/or splenic surgery

  • History of duodenal or gastric ulcers or regularly taking medications (therapy >1 day per week) that can cause ulcers (e.g., non-steroidal anti-inflammatory drugs)
  • Prior radiation to the upper abdomen
  • Prior embolization to the stomach, spleen or liver
  • Portal venous hypertension
  • Active H. pylori infection
  • Uncontrolled hypertension (> 160/100 with or without medication).
  • Diabetes (determined by medical history, fasting blood glucose or results of an oral glucose tolerance test)
  • Serum triglyceride > 400 mg/dL at screening.
  • Class 4 or 5 surgical risk based on standard ASA criteria (Saklad M. Grading of patients for surgical procedures. Anesthesiol. 1941; 2:281-4).

  • Severe pulmonary or cardiovascular disease defined as a history or evidence of serious cardiovascular disease, including myocardial infarction, acute coronary syndrome, coronary revascularization, heart failure requiring medications, history of sudden cardiac death, or NYHA (New York Heart Association) class III or IV heart failure (defined below):

    • Class III: patients with marked limitation of activity; they are comfortable only at rest.
    • Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest.
  • Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5 at screening).
  • Anemia (Hb < 10.0 g/dL) at screening.
  • Malignancy in the last 5 years (except for non-melanoma skin cancer).
  • Evidence of other significant organ system dysfunction (e.g. cirrhosis, renal failure)
  • Pregnant or lactating.
  • History of substance abuse in last 3 years.
  • Thyroid Stimulating Hormone (TSH) >2.0 x upper limit of normal at screening.
  • Taking prescription or over-the-counter medications for weight loss in the last 3 months before screening, or planning to participate in a commercial weight loss program in the next 5 years.
  • Taking diuretic medication for congestive heart failure or edema.
  • Evidence of significant mucosal inflammation, ulceration or ischemia detected on endoscopy, and those with unsuitable left gastric anatomy as judged by the study site physician will be excluded
  • Psychiatric illness that could affect compliance with the study, as judged by the site principle investigator.
  • Unable to complete screening requirements (compliance with visits and dietary record)
  • Taking medication once or more per week that causes weight gain (e.g. atypical antipsychotics, monoamine oxidase inhibitors, lithium, selected anticonvulsants, tamoxifen, glucocorticoids)
  • Chronic abdominal pain that would potentially complicate management.
  • Unstable weight (>3% change; self-reported) over the previous 2 months at time of screening.
  • Subjects whom the site investigator, research team, or the study medical monitor feel is not able to participate in the study for any reason, including poor general health or unable/unwilling to follow the study protocol.