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

Non-Small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03056300
• Other study ID #: ESC-14-006
• Status: Completed
• Phase: N/A
• Start date: January 11, 2017
• Est. completion date: May 26, 2017

Study information

• Verified date: January 2019
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Device:
• Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Powered Vascular Stapler used on vessels

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing City

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Intra-Operative Hemostatic Interventions	Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).	Intra-Operative
Primary	Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding	Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS: Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection).; No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).	Post-op through 4 week follow-up