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N/A N=50 Treatment

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

Lung Cancer

Enrolled (actual)
50
Serious AEs
21.3%
Results posted
Jul 2014
Primary outcome: Primary: Incidence of Prolonged Air Leaks — 5 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
ENDO GIA™ Stapler with TRI-STAPLE™ Technology (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medtronic - MITG
Primary completion
Oct 2011

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

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).

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.

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