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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ENDO GIA™ Stapler with TRI-STAPLE™ Technology

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

Group Type EXPERIMENTAL

ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Intervention Type DEVICE

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

Interventions

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ENDO GIA™ Stapler with TRI-STAPLE™ Technology

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No