Safety and Efficacy Study of Duet TRS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT00950872
First received: July 30, 2009
Last updated: March 31, 2014
Last verified: March 2014
  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: 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:
  • Incidence of Adverse Events. [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operating Room (OR) Time [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 2 (Approximately 1.5 days post randomization) ] [ Designated as safety issue: No ]
    Days spent in the hospital

  • Incidence of Stapler 'Misfires' [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Covidien
ClinicalTrials.gov Identifier: NCT00950872     History of Changes
Other Study ID Numbers: AS08016
Study First Received: July 30, 2009
Results First Received: December 17, 2013
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014