A study to evaluate the safety and efficacy of AspireAssist™ in morbidly obese adolescents

INTERVENTION: This AspireAssist study is an interventional study with a control. The study is designed as a two‐arm study with randomization in the proportion of 20 subjects in the treatment group receiving the AspireAssist and 20 subjects in the control group receiving conservative treatment. 20 patients who will undergo implantation of the AspireAssist Device and complete the study protocol in the 12 months following the implantation of the device. Obese adolescents will be enrolled into one of the two arms of the study: Arm 1: Obese patients with the AspireAssist device Arm 2: Obese patients treated conservatively The intervention requires percutaneous endoscopic placement of the A‐Tube which is similar to a standard PEG tube, in adolescent subjects with BMI of between 35 and 55 kg/m2. The tube is then used to drain the remaining stomach contents to reduce the caloric intake from the meal. This aspiration process is intended to be performed 20 minutes after each major meal of the day (3x per day) to achieve weight loss. The device is currently CE Marked and commercially available in the EU. The therapy has already been the subject of several studies and is also the subject of a randomized controlled trial in adult subjects in the US under ClinicalTrials.gov NCT01766037. CONDITION: Adolescent obesity ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Body weight reduction measured as % Total Body Weight loss will be evaluated at 3, 6 and 12 months of treatment. SECONDARY OUTCOME: 1. Waist circumference and BMI changes; 2. Body composition changes – evaluation of fatty tissue volume reduction; 3. Tolerance of the aspiration method by adolescents (to be measured with AspireAssist patient satisfaction survey); 4. Changes in food intake and dietary habits (to be measured with AspireAssist patient satisfaction survey); 5. Quality of life improvement assessed by means of IWQOL and SF‐36.; ; These are all evaluated at 3, 6 and 12 months. INCLUSION CRITERIA: 1. Age 16 to 21 years at the time of selection for the study 2. Body mass index (BMI) 35 to 55 kg/ m2 3. Comorbidities such as hypertension and dyslipidemia treated by an appropriate specialist are permissible 4. Ability to comprehend the content of the informed consent form. 5. Cooperation of the subject's parents 6. Non‐smoker