Safety and Efficacy Study of Duet TRS

Not Applicable

Completed

• Conditions: Roux En Y Gastric Bypass
• Interventions: Device: Duet TRS

• Registration Number: NCT00950872
• Lead Sponsor: Medtronic - MITG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-31
• Study First Posted: 2009-08-03
• Study Start: 2009-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2013-12-17
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-31
• Last Update Submitted: 2014-03-31
• Results First Posted: 2014-05-01
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Duet TRS	Duet TRS	Subjects receive Duet TRS

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events.	Day 30

Secondary Outcome Measures

Name	Time	Method
Operating Room (OR) Time	Day 0	OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.
Length of Hospital Stay	Day 2 (Approximately 1.5 days post randomization)	Days spent in the hospital
Incidence of Stapler 'Misfires'	Day 0	The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States