Tri Staple Technology Stapler Used in Gastric Bypass

Last updated: January 29, 2014
Sponsor: Medtronic - MITG
Overall Status: Completed

Phase

N/A

Condition

Williams Syndrome

Esophageal Disorders

Diabetic Neuropathy

Treatment

N/A

Clinical Study ID

NCT01026103
AS09004
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 followingcomorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease,gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible forgastric bypass.

  • The patient must be willing and able to participate in the study procedures and ableto understand and sign the informed consent.

Exclusion

Exclusion Criteria:

  • The procedure is needed as revision bariatric surgery or the patient has had priorgastric 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-upschedule, 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

Study Design

Total Participants: 28
Study Start date:
January 01, 2010
Estimated Completion Date:
March 31, 2011

Connect with a study center

  • Clarian Bariatric Center/Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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