Tri Staple Technology Stapler Used in Gastric Bypass

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-03-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tri Staple

This is a single arm study.

Group Type EXPERIMENTAL

Tri Staple Technology stapler

Intervention Type DEVICE

This is a single arm study.

Interventions

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Tri Staple Technology stapler

This is a single arm study.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes