Safety and Efficacy Study of Duet TRS

Completed · Not applicable

Conditions studied: Roux En Y Gastric Bypass

In brief

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.

Key facts

Study ID

NCT00950872

Run by

Medtronic - MITG

People needed

29

Starts

2009-11-01

Expected to finish

2010-09-01

Last updated by the study team

2014-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.