Health Condition 1: E669- Obesity, unspecified Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: EndoSleeveâ?¢ System
: Evaluation of the safety and
performance of the EndoSleeveâ?¢ System in over-weight or obese
patients with Type 2 diabetes mellitus. Total duration of the Therapy
Sponsors
Metamodix Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age > 18 years and 2. BMI > 25 kg/m2 and 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 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary safety endpoint is the incidence of all serious device or procedure related adverse events. 2. The primary performance endpoint is the percent of subjects who have successful device implantation and removal after 3 months, defined as deployment of the EndoSleeveâ?¢ Gastrointestinal Bypass Liner at the intended location and subsequent successful endoscopic device retrieval. Timepoint: 3 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Body weight 2. Change in activated C-Peptide, Serum Insulin and HbA1c (%) 3. Percent excess weight lossTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactNaresh Kumar Pagidimarry
Galaxy Care Laparoscopy Institute
Outcome results
None listed