Tri Staple Technology Stapler Used in Gastric Bypass

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Tri Staple Technology stapler


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tri Staple<br>This is a single arm study. | Device: Tri Staple Technology stapler<br>* This is a single arm study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With an Uneventful Creation of a Functional Staple Line |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric bypass, Gastric bypass surgery