Safety and Efficacy Study of Duet TRS

A Prospective, Single-Center Investigation of the Safety and Performance of the ENDO GIA Staplers With ENDO GIA Single Use Loading Units With DUET TRS TM in a Gastric Bypass Procedure

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.

Study Overview

• Status: Completed
• Conditions: Roux En Y Gastric Bypass
• Intervention / Treatment: Device: Duet TRS

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duet TRS; Subjects receive Duet TRS	Device: Duet TRS; Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating Room (OR) Time	OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.	Day 0
Length of Hospital Stay	Days spent in the hospital	Day 2 (Approximately 1.5 days post randomization)
Incidence of Stapler 'Misfires'	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.	Day 0

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Aurora Pryor, MD, Duke University

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 31, 2009
• First Posted (Estimate): August 3, 2009

Study Record Updates

• Last Update Posted (Estimate): May 1, 2014
• Last Update Submitted That Met QC Criteria: March 31, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: AS08016