A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies

Ethicon

Status: Completed

Conditions: Non-Small Cell Lung Cancer

Treatments: Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Study type: Interventional

Funder types: Industry

Identifiers

NCT03056300

ESC-14-006

Details and patient eligibility

About

The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
2. Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
3. Performance status 0-1 (Eastern Cooperative Oncology Group classification);
4. ASA score < 3;
5. No prior history of VATS or open lung surgery (on the lung in which the procedure will be performed);
6. Willing to give consent and comply with study-related evaluation and treatment schedule; and
7. 18-75 years of age (inclusive).

Exclusion criteria

1. Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
2. Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
3. Uncontrolled diabetes mellitus;
4. End stage renal or liver disease;
5. History of severe cardiovascular disease;
6. FEV1% <50% or severe COPD;
7. Prior chemotherapy or radiation for lung cancer;
8. Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
9. Robotic-assisted procedure;
10. Women who are pregnant or lactating at the time of screening;
11. Physical or psychological condition which would impair study participation;
12. The subject is judged unsuitable for study participation by the Investigator for any other reason;
13. Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
14. Unable or unwilling to attend follow-up visits and examinations.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Powered vascular stapler

Experimental group

Description:

Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Treatment:

Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler