A Multicenter Study for Pre-Surgical Weight Loss

Not Applicable

Completed

Conditions: Obesity

Interventions: Device: EndoBarrier Device
Behavioral: Diet & Lifestyle Counseling

Registration Number: NCT00830440

Lead Sponsor: Morphic Medical Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 43

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EndoBarrier Device	EndoBarrier Device	EndoBarrier Device and Diet \& Lifestyle Counseling
EndoBarrier Device	Diet & Lifestyle Counseling	EndoBarrier Device and Diet \& Lifestyle Counseling
Control	Diet & Lifestyle Counseling	Diet \& Lifestyle Counseling

Primary Outcome Measures

Name	Time	Method
Total Weight Change From Baseline at 12 Weeks in kg	12 weeks

Secondary Outcome Measures

Name	Time	Method
% of Subjects Achieving at Least a 10% Change in Excess Weight From Baseline to 12 Weeks	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.
Count of Subjects With Decrease in HbA1c Values From Baseline to Week 12	Baseline to Week 12 of treatment