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Completed

NCT Number: NCT01241565

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedar Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENDO GIA™ Stapler with TRI-STAPLE™ Technology

Device

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

Primary outcomes

  1. Incidence of Prolonged Air Leaks

    Time frame: Day 30

    Defined as > 5 days by the Society for Thoracic Surgery

Secondary outcomes

  1. Incidence of Air Leaks

    Time frame: Day 30

    As recorded on the air leak log.

  2. Duration of Air Leak

    Time frame: Day 30

    Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.

  3. Length of Hospital Stay

    Time frame: Approximately Day 6

  4. Duration of Chest Tube Following Surgery

    Time frame: Approximately Day 5

    Chest tube duration was calculated as removal date - placement date + 1

  5. Incidence of Serosal Tearing

    Time frame: Day 30

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 16, 2010
Registry last updated
Jul 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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