Clinical trial NCT01026025: Duet TRS Used in Pulmonary Resections
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Cancer
Keywords: lobectomy
segmentectomy
pulmonary resection
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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.
timeFrame: intra-operative and 1 month follow up
Secondary outcomes:
measure: The secondary objectives are length of hospital stay, duration of chest tube following surgery and need for Heimlich valve at discharge.
timeFrame: discharge and 1 month follow up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Hiran C Fernando, MD
role: PRINCIPAL_INVESTIGATOR
References: