N/A
N=201
Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02702921 ↗Enrolled (actual)
201
Serious AEs
19.9%
Results posted
Jun 2018
Primary outcome: Primary: Incidence of Intra-Operative Hemostatic Intervention — 0.0533; 0.0833 Proportion transections w/ intervention
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surgeon's 'standard of care' stapler (Device); Ethicon Powered Vascular Stapler (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Intra-Operative Hemostatic Intervention |
0.0533; 0.0833 | — |
| SECONDARY Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding |
0.0104; 0.0095 | — |
Summary
This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current Standard Of Care stapler (for Pulmonary Artery/Pulmonary Vein transection) and powered vascular stapler.
Eligibility Criteria
Inclusion Criteria
- Subjects with a confirmed or suspected diagnosis of stage IA to stage IIIA non-small cell lung cancer scheduled for a lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)5;
- Subjects scheduled for VATS lobectomy in accordance with their institution's Standard Of Care;
- Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- American Society of Anesthesiologists (ASA) score </= 3;
- No prior history of VAT or open lung surgery (on the lung in which the procedure will be performed);
- Willing to give consent and comply with study-related evaluation and treatment schedule; and
- At least 18 years of age.
Exclusion Criteria
- Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment);
- Pregnancy;
- Physical or psychological condition which would impair study participation; or
- The subject is judged unsuitable for study participation by the Investigator for any other reason.
Data sourced from ClinicalTrials.gov (NCT02702921). 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.