Health Condition 1: null- Type II diabetes patients which are candidate for bariatric surgery
Conditions
Interventions
Intervention1: Gastro-Duodenal Sleeve (GDS): The Gastro-Duodenal Sleeve (GDS) is a temporary device which has a similar mechanism of action as the GI Dynamics EndoBarrier system with an improved atrau
Sponsors
Allevetix Ltd
Eligibility
Inclusion criteria
Inclusion criteria: This study will include subjects who meet all of the following: 1. Both male and female patients 2. Patient is at least 18 years old 3. Anticipated patient life expectancy of at least 1 year from enrolment 4. Patient providing written Informed Consent Form to participate in the study prior to any study related procedures 5. Patient is willing to comply with the protocol requirements and return to the study center for all required clinical evaluations 6. Patient Baseline BMI of >= 30 kg/m2 and 7. Type 2 diabetes mellitus with HbA1c >= 8 in the 6 months before enrolment 8. Sexually active women, unless surgically sterile or post menopausal, must use one of the following methods to avoid pregnancy during the study: 1. Abstinence from penile/vaginal intercourse during the study; 2. Double barrier contraceptive methods 1 of which must be condom.
Exclusion criteria
Exclusion criteria: The patients will be excluded from the study based on the following exclusion criteria: 1. Use of weight loss medications or appetite suppressants since last 1 month 2. Use of non-steroidal anti-inflammatory drugs, corticosteroids, and drugs known to affect gastrointestinal motility since last 3 month 3. Pancreatitis in the last 1 month, symptomatic coronary artery disease (NYHA 4. History of gastrointestinal tract abnormalities, including gastrointestinal bleeding conditions 5. Patients having anemia/ iron deficiency 6. Patient with known peptic ulcer, gastritis, duodenitis, esophagitis, varices 7. History or symptoms of scleroderma 8. Previous surgery in the gastrointestinal tract that could affect the ability to place the study device 9. Current infection 10. Any malignancy 11. HIV, HCV, HBV positive 12. Alcohol abuse 13. Congenital or acquired abnormalities of the gastrointestinal tract 14. Pregnant female or intention to become pregnant within the next 16 weeks 15. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study 16. Patient should not take anti-coagulants and/or anti-aggregates for 10 days prior the device placement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Endpoints: Incidence and severity of device and procedure related adverse events. Performance Endpoint: â?¢ Change in HbA1c from baseline â?¢ Percentage of weight loss from baseline â?¢ Evaluation of device usability Timepoint: Safety Endpoints: Incidence and severity of device and procedure related adverse events: Day 84 (Visit 05) Performance Endpoint: â?¢ Change in HbA1c from baseline: Day 112 (Visit 06 - End of Study) â?¢ Percentage of weight loss from baseline: Day 112 (Visit 06 - End of Study) â?¢ Evaluation of device usability: Day 84 (Visit 05) | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr. Sandeep Singh
Allevetix Ltd
Outcome results
None listed