Clinical trial NCT03056300: A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Incidence of Intra-Operative Hemostatic Interventions
timeFrame: Intra-Operative
measure: Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
timeFrame: Post-op through 4 week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing City
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Keneng Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Services
name: Shugeng Gao
role: PRINCIPAL_INVESTIGATOR
affiliation: The first affiliated hospital Zhejiang University/Hangzhou
name: Hu Jian
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship hospital/Hangzhou
name: Li Jian
role: PRINCIPAL_INVESTIGATOR
References: