Safety and Efficacy Study of Duet TRS

This study has been completed.
Sponsor:
Information provided by:
Covidien
ClinicalTrials.gov Identifier:
NCT00950872
First received: July 30, 2009
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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 Intervention
Roux En Y Gastric Bypass
Device: Duet TRS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Covidien:

Primary Outcome Measures:
  • The overall performance of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM as measured by the creation of a normal staple line. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • The incidence of Adverse Events. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operating room (OR) time [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Length of stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Incidence of stapler malfunction [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duet TRS
Single arm study, all patients receive the test device.
Device: Duet TRS
ENDO GIA stapler with integrated Duet TRS
Device: Duet TRS
All patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950872

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Aurora Pryor, MD Duke University
  More Information

No publications provided

Responsible Party: Stephanie Marcucio, Clinical Research Associate II, Covidien
ClinicalTrials.gov Identifier: NCT00950872     History of Changes
Other Study ID Numbers: AS08016
Study First Received: July 30, 2009
Last Updated: April 18, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014