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

Medtronic

Status: Completed

Conditions: Lung Cancer

Treatments: Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Study type: Interventional

Funder types: Industry

Identifiers

NCT01241565

COVEGTT0027

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Experimental group

Description:

Single arm study, all patients will receive the study device.

Treatment:

Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology