A Multicenter Study for Pre-Surgical Weight Loss

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and initial efficacy of the EndoBarrier device compared to a diet control in patients who require weight loss prior to their Bariatric surgery. It is a randomized, prospective controlled, open label, pilot study of 40 patients. Thiry patients will receive an implant of the EndoBarrier device and the other 10 patients will receive the principle investigator's standard of care diet program. All patients will be treated for 12 weeks with the exception of the last 10 device patients who will continue to 24 weeks if the principle investigator determines that it is safe and in their best interest to continue. The primary efficacy endpoint is: Assessment of the difference in % excess weight loss between the 2 groups Secondary endpoints are: Resolution or Improvement in type II Diabetic status as defined as: Resolution = patient is off their diabetes medication and has normal diabetic blood parameters (fasting glucose) Improvement = normalizing diabetic blood parameters (fasting glucose) and/or a reduction in dosing or frequency of their diabetic medication The percent of patients who achieve at least a 10% excess weight loss will be calculated as a secondary outcome.

Official Title
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A Multi-Center, Pilot Efficacy Study of the GI Sleeve™ for Pre-Surgical Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Device: EndoBarrier Device
* Behavioral: Diet & Lifestyle Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years and < 55 years - Male or Female BMI > 35 with significant comorbidities (i.e. hypertension, or hyperlipidemia, or diabetes) or > 40 BMI <60 (with or without a co-morbid condition) History of failure with nonsurgical weight loss methods Candidates for Roux-en-Y gastric bypass Patients willing to comply with study requirements Patients who have signed an informed consent form Exclusion Criteria: Patients requiring prescription anticoagulation therapy Patients with iron deficiency and iron deficiency anemia Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease Treatment represents an unreasonable risk to the patient Pancreatitis or other serious organic conditions Symptomatic coronary artery disease or pulmonary dysfunction Patients with known gallstones prior to implant Known infection at the time of implant Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia Congenital or acquired anomalies of the GI tract such as atresias or stenoses Pregnant or has the intention of becoming pregnant in the next 12 months Unresolved alcohol or drug addiction HIV Positive patients Patients with hepatitis B or C Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial Previous GI surgery that could affect the ability to place the sleeve or the function of the implant. Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated) Patients receiving weight loss medications such as Meridia and Xenical Family or patient history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder Patients with gastroesophageal reflux disease (GERD) Patients with a history of kidney stones Participating in another ongoing investigational clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoBarrier Device<br>EndoBarrier Device and Diet & Lifestyle Counseling | Device: EndoBarrier Device<br>* NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp and EndoBarrier Device for 12 weeks<br>* Other names: EndoBarrier Gastrointestinal Liner;Behavioral: Diet & Lifestyle Counseling<br>* NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp<br>|
| Active Comparator: Control<br>Diet & Lifestyle Counseling | Behavioral: Diet & Lifestyle Counseling<br>* NIH derived dietary, exercise and behavior modification 2005 guidelines. https://health.gov/dietaryguidelines/2005.asp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Weight Change From Baseline at 12 Weeks in kg |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks | The percent excess weight loss calculated using the Metropolitan Life Tables (MET). The actual amount of excess weight loss (EWL) was examined through the percent of actual weight change from baseline. | 12 weeks | 
| Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12 |  | Baseline to Week 12 of treatment |