Status:
COMPLETED
Safety and Efficacy Study of Duet TRS
Lead Sponsor:
Medtronic - MITG
Conditions:
Roux En Y Gastric Bypass
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00950872
Start Date
November 1 2009
End Date
September 1 2010
Last Update
May 1 2014
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710