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

Study Overview
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Brief Summary
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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).

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

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENDO GIA™ Stapler with TRI-STAPLE™ Technology<br>Single arm study, all patients will receive the study device. | Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology<br>* All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Prolonged Air Leaks | Defined as > 5 days by the Society for Thoracic Surgery | Day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Air Leaks | As recorded on the air leak log. | Day 30 | 
| Duration of Air Leak | Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge. | Day 30 | 
| Length of Hospital Stay |  | Approximately Day 6 | 
| Duration of Chest Tube Following Surgery | Chest tube duration was calculated as removal date - placement date + 1 | Approximately Day 5 | 
| Incidence of Serosal Tearing |  | Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, lobectomy, wedge resection