CTRI/2019/02/017436已完成未知
A Feasibility Study to Evaluate the Safety and Performance of theEndoSleeveâ?¢ System in Over-weight or Obese patients withType 2 Diabetes Mellitus
Metamodix Inc0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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 > 25 kg/m2 and < 40 kg/m2
- •3. Patient with Type 2 Diabetes and being treated by diet or
- •oral anti-diabetes agents (Metformin, DPP-4i, SU or TZD)
- •4. HbA1c at screening > 7.0 and < 10.0%
- •5. Patient or legal 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
- •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
- •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
- •23. Patient is participating in another ongoing clinical study
研究者
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