Tri Staple Technology Stapler Used in Gastric Bypass

Completed · Not applicable

Conditions studied: Sleep Apnea, Hypertension, Hyperlipidemia, Coronary Artery Disease, Gastroesophageal Reflux Disease, Osteoarthritis, Diabetes

In brief

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.

Key facts

Study ID

NCT01026103

Run by

Medtronic - MITG

People needed

28

Starts

2010-01-01

Expected to finish

2011-03-01

Last updated by the study team

2014-03-14

Who can join

Age: 18 and older, up to 65. 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 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.

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 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

Where it is running

• Clarian Bariatric Center/Indiana University — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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