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Tri Staple Technology Stapler Used in Gastric Bypass - NCT01026103-46202(Clinical Trial 425040)



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City:  Indianapolis
State:  
IN
Zip Code: 46202
Conditions: Sleep Apnea - Hypertension - Hyperlipidemia - Coronary Artery Disease - Gastroesophageal Reflux Disease - Osteoarthritis - Diabetes
Purpose: The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
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 one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass. - 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 requiring mesh repair - The patient has a history of clinically significant liver disease - The patient has a history of drug or alcohol abuse within 2 years of enrollment - 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: June 23, 2010
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