Study for Short Term Weight Loss in Candidates for Bariatric Surgery

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 46

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
Willing to comply with trial requirements
Signed an ICF
Post-menopausal women with surgical sterilization or following any treatment or family planning and not planning to become pregnant during the course of the investigation

Exclusion Criteria

Treatment represents an unreasonable risk to the subject
Pregnant or have intention of becoming pregnant for the duration of the trial
Unresolved alcohol or drug addiction
Receiving weight loss medications (prescription, over-the-counter, or herbal dietary medications)
Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Liner or the function of the implant
Active GERD
Symptomatic kidney stones prior to implant
Iron deficiency and/or iron deficiency anemia
History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
Symptomatic gallstones prior to implant
Symptomatic coronary artery disease or pulmonary dysfunction
Known infection at the time of implant
History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
Pancreatitis or other serious organic conditions
Requiring prescription anticoagulation therapy
Unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
Having or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
Participating in another ongoing investigational clinical trial
Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial
Active Helicobacter pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated)
Having or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device	Endobarrier Liner	All patients will be implanted with the Endobarrier Liner device.

Primary Outcome Measures

Name	Time	Method
Assessment of % Excess Weight Loss	12 months	Primary efficacy was assessment of the percent excess weight loss (%EWL) at Week 52 or last assessment. Excess weight was determined from ideal body weights based on a body mass index (BMI) of 25 kg/m2. Percent excess weight loss from baseline to 12 months was calculated as \[(baseline weight minus the 12-month weight) / (baseline weight minus the ideal body weight)\] \* 100).

Secondary Outcome Measures