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

Ethicon

Status: Completed

Conditions: Non Small Cell Lung Cancer

Treatments: Device: Surgeon's 'standard of care' stapler; Device: Ethicon Powered Vascular Stapler

Study type: Interventional

Funder types: Industry

Identifiers

NCT02702921

ESC-15-001

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Surgeon's 'standard of care' stapler

Active Comparator group

Description:

Surgeon's current standard of care stapler

Treatment:

Device: Surgeon's 'standard of care' stapler

Ethicon Powered Vascular Stapler

Experimental group

Description:

Ethicon Powered Vascular Stapler

Treatment:

Device: Ethicon Powered Vascular Stapler