N/A
N=50
ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01241565 ↗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
| Outcome | Result | p-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
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.