ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01241565
First received: October 18, 2010
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).


Condition Intervention
Lung Cancer
Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Incidence of Prolonged Air Leaks [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Defined as > 5 days by the Society for Thoracic Surgery


Secondary Outcome Measures:
  • Incidence of Air Leaks [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    As recorded on the air leak log.

  • Duration of Air Leak [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
    Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.

  • Length of Hospital Stay [ Time Frame: Approximately Day 6 ] [ Designated as safety issue: No ]
  • Duration of Chest Tube Following Surgery [ Time Frame: Approximately Day 5 ] [ Designated as safety issue: No ]
    Chest tube duration was calculated as removal date - placement date + 1

  • Incidence of Serosal Tearing [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
Single arm study, all patients will receive the study device.
Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject must be 18 years of age or older.
  • The subject must be scheduled to undergo wedge resection or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer.
  • The subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure.
  • The subject must be willing and able to comply with all study requirements and have understood and signed the informed consent.

Exclusion Criteria:

  • The subject is pregnant or breastfeeding.
  • The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease.
  • A rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. VATS procedures that are converted in the operating room to open procedures are not exclusionary.
  • The subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected.
  • The subject is scheduled to receive intra-operative brachytherapy.
  • The subject has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months.
  • Re-operative surgery is excluded if it is on the same side as the previous surgery.
  • Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
  • The subject is unable to comply with the follow-up visit schedule
  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: NCT01241565

Locations
United States, California
Cedar Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Covidien
Investigators
Principal Investigator: Robert McKenna, MD Cedar Sinai Medical Center
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01241565     History of Changes
Other Study ID Numbers: COVEGTT0027
Study First Received: October 18, 2010
Results First Received: March 31, 2014
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Covidien:
lung cancer
lobectomy
wedge resection

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014