Safety and Efficacy Study of Duet TRS

Medtronic

Status: Completed

Conditions: Roux En Y Gastric Bypass

Treatments: Device: Duet TRS

Study type: Interventional

Funder types: Industry

Identifiers

NCT00950872

AS08016

Details and patient eligibility

About

The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.

Enrollment: 29 patients

Sex: All

Ages: 18+ 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 comorbidities
• 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
• The patient has a history of liver disease
• The patient has a history of drug or alcohol abuse
• The patient has a history of venous thrombosis or pulmonary embolism
• The patient has a history of coagulopathy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Duet TRS

Experimental group

Description:

Subjects receive Duet TRS

Treatment:

Device: Duet TRS