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

Completed · Not applicable

Conditions studied: Lung Cancer

In brief

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).

Key facts

Study ID

NCT01241565

Run by

Medtronic - MITG

People needed

50

Starts

2010-11-01

Expected to finish

2011-10-01

Last updated by the study team

2014-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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