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

Launched by MEDTRONIC - MITG · Nov 15, 2010

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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