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

NCT ID: NCT03056300

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-11
• Study Completion Date: 2017-05-26

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Powered vascular stapler

Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Group Type: EXPERIMENTAL

Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Intervention Type: DEVICE

Powered Vascular Stapler used on vessels

Interventions

Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Powered Vascular Stapler used on vessels

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keneng Chen

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Shugeng Gao

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Services

Hu Jian

Role: PRINCIPAL_INVESTIGATOR

The first affiliated hospital Zhejiang University/Hangzhou

Li Jian

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship hospital/Hangzhou

Locations

Beijing Cancer Hospital

Beijing, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ESC-14-006

Identifier Type: -

Identifier Source: org_study_id