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N/A Completed N=50 Treatment

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

Source: ClinicalTrials.gov NCT01241565 ↗
Enrolled (actual)
50
Serious AEs
21.3%
Results posted
Jul 2014
Primary outcomePrimary: Incidence of Prolonged Air Leaks — 5 participants

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).

Outcome Measures

OutcomeResultp-value
PRIMARY
Incidence of Prolonged Air Leaks
5 —
SECONDARY
Incidence of Air Leaks
33 —
SECONDARY
Duration of Air Leak
3.52 —
SECONDARY
Length of Hospital Stay
6.32 —
SECONDARY
Duration of Chest Tube Following Surgery
5.02 —
SECONDARY
Incidence of Serosal Tearing
2 —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01241565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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