Clinical trial NCT01241565: ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
Official title: A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
lobectomy
wedge resection
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).


Eligibility 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

Primary outcomes:
measure: Incidence of Prolonged Air Leaks
timeFrame: Day 30
Secondary outcomes:
measure: Incidence of Air Leaks
timeFrame: Day 30
measure: Duration of Air Leak
timeFrame: Day 30
measure: Length of Hospital Stay
timeFrame: Approximately Day 6
measure: Duration of Chest Tube Following Surgery
timeFrame: Approximately Day 5
measure: Incidence of Serosal Tearing
timeFrame: Day 30
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedar Sinai Medical Center
state: California
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Cedar Sinai Medical Center
name: Robert McKenna, MD
role: PRINCIPAL_INVESTIGATOR
References: