Tri Staple Technology Stapler Used in Gastric Bypass

Not Applicable

Completed

• Conditions: Sleep Apnea; Hypertension; Hyperlipidemia; Coronary Artery Disease; Gastroesophageal Reflux Disease; Osteoarthritis; Diabetes
• Interventions: Device: Tri Staple Technology stapler

• Registration Number: NCT01026103
• Lead Sponsor: Medtronic - MITG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Study Start: 2010-01
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-01
• Results First Submitted: 2014-01-29
• Results First Submitted QC: 2014-01-29
• Last Update Submitted: 2014-01-29
• Results First Posted: 2014-03-14
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tri Staple	Tri Staple Technology stapler	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With an Uneventful Creation of a Functional Staple Line	Day 0

Secondary Outcome Measures

Name	Time	Method
Incidence of Intra-operative Bleeding Requiring Intervention	Day 0 and 1 month
Length of Hospital Stay	Date of discharge which averages 3 days
Incidence of Serosal Tearing	30 days post op

Trial Locations

Locations (1)

Clarian Bariatric Center/Indiana University; 🇺🇸 Indianapolis, Indiana, United States