N/A Completed N=201 Randomized Treatment

Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies

Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov NCT02702921 ↗

Enrolled (actual)

201

Serious AEs

19.9%

Results posted

Jun 2018

Primary outcomePrimary: Incidence of Intra-Operative Hemostatic Intervention — 0.0533; 0.0833 Proportion transections w/ intervention

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.