Safety and Efficacy Study of Duet TRS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00950872
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Roux En Y Gastric Bypass Device: Duet TRS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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.

Primary Outcome Measures :
  1. Incidence of Adverse Events. [ Time Frame: Day 30 ]

Secondary Outcome Measures :
  1. Operating Room (OR) Time [ Time Frame: 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.

  2. Length of Hospital Stay [ Time Frame: Day 2 (Approximately 1.5 days post randomization) ]
    Days spent in the hospital

  3. Incidence of Stapler 'Misfires' [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00950872

United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Medtronic - MITG
Principal Investigator: Aurora Pryor, MD Duke University

Responsible Party: Medtronic - MITG Identifier: NCT00950872     History of Changes
Other Study ID Numbers: AS08016
First Posted: August 3, 2009    Key Record Dates
Results First Posted: May 1, 2014
Last Update Posted: May 1, 2014
Last Verified: March 2014