Know Cancer

forgot password

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

18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of prolonged air leaks, defined as > 5 days by the Society for Thoracic Surgery

Outcome Time Frame:

30 days

Safety Issue:


Principal Investigator

Robert McKenna, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedar Sinai Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2010

Completion Date:

October 2011

Related Keywords:

  • Lung Cancer
  • lung cancer
  • lobectomy
  • wedge resection
  • Lung Neoplasms



Mayo Clinic Rochester, Minnesota  55905
Advocate Christ Medical Center Oak Lawn, Illinois  60453
Cedar Sinaï Medical Center Los Angeles, California  CA90048