CTRI/2019/02/017436
Completed
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 sites15 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: E669- Obesity, unspecifiedHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications
- Sponsor
- Metamodix Inc
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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