Duet TRS Used in Pulmonary Resections

Study Overview
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Brief Summary
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The objectives of this clinical trial are to estimate 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 Staplers with ENDO GIA Single Use Loading Units (SULUs) buttressed with Duet TRS TM in an anatomic pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS). Anatomic pulmonary resection is defined as either a lobectomy or segmental resection. Results of the study will be compared to contemporary literature for a similar population.

Official Title
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A Prospective, Multi-Center Evaluation of Endo GIA Staplers With Endo GIA Single Use Loading Units (SULUs) With Duet TRS TM in a Pulmonary Resection

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: Duet TRS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be 18 years of age or older The patient must be scheduled to undergo segmentectomy or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer The patient must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure The patient must be willing and able to comply with all study requirements and have understood and signed the informed consent. Exclusion Criteria: The patient is pregnant or breastfeeding The patient is scheduled to undergo sleeve lobectomy, wedge resection, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease The patient has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected The patient is scheduled to receive intra-operative brachytherapy The patient 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 The patient requires chest wall reconstruction

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duet TRS<br>This is a single arm study. | Device: Duet TRS<br>* This is a single arm study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objectives of this clinical trial are to estimate the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days)in an anatomic pulmonary resection. |  | intra-operative and 1 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives are length of hospital stay, duration of chest tube following surgery and need for Heimlich valve at discharge. |  | discharge and 1 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lobectomy, segmentectomy, pulmonary resection