CTRI/2018/10/015928尚未招募未知
A Feasibility Study to Evaluate the Safety and Performance of the EndoSleeveâ?¢ System in Obese patients with or without Type 2 Diabetes Mellitus - ES01
Metamodix Inc0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age > 18 years and < 65 years â?? Male or Female
- •2. BMI > 27.5 kg/m2 and < 40 kg/m2
- •3. Obese non-diabetes patients or Obese Type 2 Diabetes patients with HbA1c at screening > 7.0 and < 10.0% and being treated by diet or oral anti-diabetes agents (Metformin, DPP-4i, SU or TZD)
- •4. Patient or legally authorized representative of the patient is willing and able to sign an IEC approved informed consent form and agrees to comply with study requirements
排除标准
- •1. Patients requiring injectable treatments (insulin, GLP-1R agonists)
- •2. Patients with Type 1 Diabetes Mellitus or having any history of ketoacidosis
- •3. Patients with iron deficiency and iron deficiency anemia
- •4. Patients requiring anticoagulation therapy
- •5. Patients with inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohnâ??s disease
- •6. Patients with pancreatitis or other serious organic conditions
- •7. Patients with known gallstones prior to implant
- •8. Patients with known infection at the time of implant
- •9. Patients with severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- •10. Patients with symptomatic coronary artery disease or pulmonary dysfunction
- •11. Patients with congenital or acquired anomalies of the GI tract such as atresiaâ??s or stenosis
- •12. Patients who are of pregnant or has the intention of becoming pregnant in the next 6 months.
- •13. Patients with unresolved alcohol or drug addiction
- •14. Patients who are HIV Positive
- •15. Patients with hepatitis B or C, chronic liver disease
- •16. Patients who are mentally retarded or emotionally unstable, or exhibit psychological characteristics which, in the opinion of the investigator, make them poor candidates for device placement or clinical trial (e.g. Eating disorder)
- •17. Patients with previous GI surgery that could affect the ability to place the sleeve or the function of the implant
- •18. Patients who are H. pylori positive (Note: patients may be enrolled if they had a prior history and were successfully treated)
- •19. Patients receiving weight loss medications (such as Meridia and Xenical)
- •20. Patients with a family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- •21. Patients with active and uncontrolled GERD
- •22. Patients with a history of kidney stones, chronic kidney disease
- •23. Patient is participating in another ongoing clinical study
研究者
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