Lung Cancer
Conditions
Keywords
lobectomy, segmentectomy, pulmonary resection
Brief summary
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.
Interventions
DEVICEDuet TRS
This is a single arm study.
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed