Duet TRS Used in Pulmonary Resections

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01026025
• Other study ID #: AS09003
• Status: Withdrawn
• Phase: N/A
• First received: December 3, 2009
• Last updated: August 5, 2013
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: August 2013
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Duet TRS
This is a single arm study.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No