Study Results
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View full resultsBasic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2009-11-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Duet TRS
Subjects receive Duet TRS
Duet TRS
Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.
Interventions
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Duet TRS
Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Medtronic - MITG
INDUSTRY
Responsible Party
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Principal Investigators
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Aurora Pryor, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Health System
Durham, North Carolina, United States
Countries
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Other Identifiers
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AS08016
Identifier Type: -
Identifier Source: org_study_id
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