Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

intra-operative and 1 month follow up

Safety Issue:

No

Principal Investigator

Hiran C Fernando, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Institutional Review Board

Study ID:

AS09003

NCT ID:

NCT01026025

Start Date:

January 2011

Completion Date:

June 2011

Related Keywords:

  • Lung Cancer
  • lobectomy
  • segmentectomy
  • pulmonary resection
  • Lung Neoplasms

Name

Location

Boston Medical CenterBoston, Massachusetts  02118
Beth Israel DeaconessBoston, Massachusetts  02215