Status:
COMPLETED
ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
Lead Sponsor:
Medtronic - MITG
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 us...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01241565
Start Date
November 1 2010
End Date
October 1 2011
Last Update
July 3 2014
Active Locations (3)
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1
Cedar Sinai Medical Center
Los Angeles, California, United States, 90048
2
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
3
Mayo Clinic
Rochester, Minnesota, United States, 55905