Status:
COMPLETED
A Multicenter Study for Pre-Surgical Weight Loss
Lead Sponsor:
Morphic Medical Inc.
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00830440
Start Date
January 1 2007
End Date
September 1 2008
Last Update
May 17 2017
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Netherlands