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

A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection

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).

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedar Sinai Medical Center
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Prolonged Air Leaks	Defined as > 5 days by the Society for Thoracic Surgery	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Air Leaks	As recorded on the air leak log.	Day 30
Duration of Air Leak	Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.	Day 30
Length of Hospital Stay		Approximately Day 6
Duration of Chest Tube Following Surgery	Chest tube duration was calculated as removal date - placement date + 1	Approximately Day 5
Incidence of Serosal Tearing		Day 30

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Robert McKenna, MD, Cedar Sinai Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: October 18, 2010
• First Submitted That Met QC Criteria: November 15, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Estimate): July 3, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: lung cancer; wedge resection; lobectomy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: COVEGTT0027