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Safety and Efficacy Study of Duet TRS - NCT00950872-27710(Clinical Trial 304454)



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City:  Durham
State:  
NC
Zip Code: 27710
Conditions: Roux En Y Gastric Bypass
Purpose: The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
Study summary:
Criteria: Inclusion Criteria: - The patient must be 18-65 years of age. - The patient has a BMI of 40-60 kg/m2 or 35-40 kg/m2 with comorbidities - The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent. Exclusion Criteria: - The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc) - The patient is pregnant. - The patient has an active, or history of, infection at the operative site. - The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent. - Patient has an abdominal ventral hernia - The patient has a history of liver disease - The patient has a history of drug or alcohol abuse - The patient has a history of venous thrombosis or pulmonary embolism - The patient has a history of coagulopathy
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Data Source: ClinicalTrials.gov
Date Processed: March 16, 2010
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