A Prospective, Single-center Investigation of the Safety and Performance of the Endo GIA™ Stapler With Endo GIA™ Sulu With Tri-Staple™ Technology in a Gastric Bypass Procedure

Medtronic - MITG1 site in 1 country28 target enrollmentJanuary 2010

ConditionsSleep Apnea Hypertension Hyperlipidemia Coronary Artery Disease Gastroesophageal Reflux Disease Osteoarthritis Diabetes

Overview

Phase: N/A
Intervention: Not specified
Conditions: Sleep Apnea
Sponsor: Medtronic - MITG
Enrollment: 28
Locations: 1
Primary Endpoint: Proportion of Patients With an Uneventful Creation of a Functional Staple Line
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

March 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic - MITG

Responsible Party

Sponsor

Eligibility 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