ISRCTN49958132已完成不适用
Aspiration Therapy for treatment of obesity with AspireAssist™ Aspiration Therapy System: a post-market study
MINA Medical (Sweden)0 个研究点目标入组 150 人开始时间: 2014年3月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25268305 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/28035287 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29388050
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •The AspireAssist Aspiration Therapy System is intended to provide gastric drainage for aspiration therapy to facilitate weight reduction in morbidly obese adults 25 to 65 years with a Body Mass Index (BMI) of >35 kg/m2, and must be used concurrently with a weight management support program.
- •Patients must have failed to lose weight or maintain long-term weight loss with more conservative weight reduction alternatives, such as diet, exercise and behavior modification programs.
排除标准
- •1. Previous abdominal surgery that significantly increases the medical risks of gastrostomy tube placement
- •2. Esophageal stricture, pseudo-obstruction, severe gastroparesis or gastric outlet obstruction, inflammatory bowel disease
- •3. History of refractory gastric ulcers
- •4. History of radiation therapy to abdomen
- •5. Uncontrolled hypertension (blood pressure>160/100)
- •6. Diabetes treated with insulin or sulfonylurea medications
- •7. Hemoglobin A1C =8.5 %
- •8. History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or NYHA (New York Heart Association) class III or IV heart failure
- •9. Coagulation disorders (platelets < 100,000, PT > 2 seconds above control or INR > 1.5)
- •10. Anemia (hemoglobin <11.0 g/dL in women and <12.5 g/dL in men)
- •11. Pregnant or lactating
- •12. Physical or mental disability, or psychological illness that could interfere with compliance with the therapy
- •13. At high risk of having a medical complication from the endoscopic procedure or Aspiration Therapy weight loss program for any reason, including poor general health or severe organ dysfunction such as cirrhosis or renal dysfunction (serum creatinine > 1.5 mg/dL, including Stage II or more severe chronic kidney disease).
- •14. Diagnosed Bulimia or diagnosed Binge Eating Disorder (using DSM IV criteria)
- •15. Serum potassium < 3.8 mEq/L.
- •16. Ulcers, bleeding lesions, or tumors discovered during endoscopic examination
- •17. Chronic abdominal pain that would potentially complicate the management of the device
研究者
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