ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection

Lung Cancer Clinical Trial

Official title:

A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241565
• Other study ID #: COVEGTT0027
• Status: Completed
• Phase: N/A
• First received: October 18, 2010
• Last updated: June 3, 2014
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• 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 compare 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™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject must be 18 years of age or older.

• The subject must be scheduled to undergo wedge resection or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer.

• The subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure.

• The subject must be willing and able to comply with all study requirements and have understood and signed the informed consent.

Exclusion Criteria:

• The subject is pregnant or breastfeeding.

• The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease.

• A rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. VATS procedures that are converted in the operating room to open procedures are not exclusionary.

• The subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected.

• The subject is scheduled to receive intra-operative brachytherapy.

• The subject 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.

• Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.

• The subject is unable to comply with the follow-up visit schedule

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• ENDO GIA™ Stapler with TRI-STAPLE™ Technology
All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Locations

Country	Name	City	State
United States	Cedar Sinai Medical Center	Los Angeles	California
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Prolonged Air Leaks	Defined as > 5 days by the Society for Thoracic Surgery	Day 30	No
Secondary	Incidence of Air Leaks	As recorded on the air leak log.	Day 30	No
Secondary	Duration of Air Leak	Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.	Day 30	No
Secondary	Length of Hospital Stay		Approximately Day 6	No
Secondary	Duration of Chest Tube Following Surgery	Chest tube duration was calculated as removal date - placement date + 1	Approximately Day 5	No
Secondary	Incidence of Serosal Tearing		Day 30	No