A clinical study, to find out the safety and performance of a medical device (Gastro Duodenal Sleeve) for weight loss in obese type II diabetic patients.
- Conditions
- Health Condition 1: null- Type II diabetes patients which are candidate for bariatric surgery
- Registration Number
- CTRI/2017/12/010784
- Lead Sponsor
- Allevetix Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
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 <= 45 kg/m2
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.
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 <3), COPD, known biliary disease (gallstone, choledocholithiasis), severe coagulopathy
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety Endpoints: Incidence and severity of device and procedure related adverse events. <br/ ><br> <br/ ><br>Performance Endpoint: <br/ ><br>â?¢ Change in HbA1c from baseline <br/ ><br>â?¢ Percentage of weight loss from baseline <br/ ><br>â?¢ Evaluation of device usability <br/ ><br>Timepoint: Safety Endpoints: Incidence and severity of device and procedure related adverse events: Day 84 (Visit 05) <br/ ><br> <br/ ><br>Performance Endpoint: <br/ ><br>â?¢ Change in HbA1c from baseline: Day 112 (Visit 06 - End of Study) <br/ ><br>â?¢ Percentage of weight loss from baseline: Day 112 (Visit 06 - End of Study) <br/ ><br>â?¢ Evaluation of device usability: Day 84 (Visit 05) <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot ApplicableTimepoint: Not Applicable