ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
- Conditions
- Lung Cancer
- Interventions
- Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
- Registration Number
- NCT01241565
- Lead Sponsor
- Medtronic - MITG
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ENDO GIA™ Stapler with TRI-STAPLE™ Technology ENDO GIA™ Stapler with TRI-STAPLE™ Technology Single arm study, all patients will receive the study device.
- Primary Outcome Measures
Name Time Method Incidence of Prolonged Air Leaks Day 30 Defined as \> 5 days by the Society for Thoracic Surgery
- Secondary Outcome Measures
Name Time Method Duration of Chest Tube Following Surgery Approximately Day 5 Chest tube duration was calculated as removal date - placement date + 1
Incidence of Serosal Tearing Day 30 Incidence of Air Leaks Day 30 As recorded on the air leak log.
Duration of Air Leak Day 30 Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.
Length of Hospital Stay Approximately Day 6
Trial Locations
- Locations (3)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Cedar Sinai Medical Center
🇺🇸Los Angeles, California, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States