A study to evaluate the safety and efficacy of AspireAssist™ in morbidly obese adolescents: a randomised controlled trial

Vítkovicke Hospital0 个研究点目标入组 40 人开始时间: 2016年8月3日最近更新: 2017年5月22日

适应症

试验速览

暂无简介。

•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

•1. BMI below 35 or above 55
•2. History of stomach and gallbladder surgeries
•3. Previous technical difficulties with gastroduodenoscopy or a failure to carry out an endoscopy
•4. Type 1 diabetes
•5. Insulin therapy
•6. History of gastrointestinal disease (acute gastritis, non-specific colitis)
•7. Confirmed celiac disease
•8. History of malignity
•9. Previous endoscopic and surgical treatment of obesity (intragastric balloons, endoscopic or surgical gastric procedures, malabsorptive procedures of the GIT)
•10. Specific genetic or hormonal disorders associated with obesity (Prader-Wili syndrome, MC4R mutation etc.)
•11. Coagulation and hemopoiesis disorders
•12. Both chronic and acute pancreatitis
•13. Psychiatric disorders (endogenous depression, schizophrenia, suicidal tendencies, psychoses)
•14. Uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg)
•15. Autoimmune diseases or long-term use of systemic glucocorticoids or immunosuppressive therapy
•16. Thyroid function disorders unresponsive to treatment
•17. Kidney function disorders with GFR < 60 mL/min/1.73 m2 or albumin excretion > 1000 mg/day

发起方

Vítkovicke Hospital