A Clinical Study to evaluate the safety and performance of the EndoSleeveâ?¢ System
- Conditions
- Health Condition 1: E70-E88- Metabolic disordersHealth Condition 2: E65-E68- Overweight, obesity and other hyperalimentation
- Registration Number
- CTRI/2018/10/015928
- Lead Sponsor
- Metamodix Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The primary safety endpoint is the incidence of all serious device or procedure related adverse events. <br/ ><br>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 and suture tether at the intended location and subsequent successful endoscopic device retrievalTimepoint: 3 Months
- Secondary Outcome Measures
Name Time Method 1. Change in Body weight <br/ ><br>2. Change in activated C-Peptide, Serum Insulin and HbA1c (%) <br/ ><br>3. Percent excess weight lossTimepoint: 3 Months