Lung Cancer Clinical Trial

Duet TRS Used in Pulmonary Resections

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Study ID:

NCT01026025

Recruitment Status:

Withdrawn

Sponsor:

Medtronic - MITG

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There is 1 Location for this study

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Beth Israel Deaconess
Boston Massachusetts, 02118, United States
Boston Medical Center
Boston Massachusetts, 02118, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Study ID:

NCT01026025

Recruitment Status:

Withdrawn

Sponsor:


Medtronic - MITG

How clear is this clinincal trial information?

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