Tri Staple Technology Stapler Used in Gastric Bypass

Medtronic

Status: Completed

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

Treatments: Device: Tri Staple Technology stapler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01026103

AS09004

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Tri Staple

Experimental group

Description:

This is a single arm study.

Treatment:

Device: Tri Staple Technology stapler