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

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702921
• Other study ID #: ESC-15-001
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: October 2018
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Surgeon's 'standard of care' stapler

• Ethicon Powered Vascular Stapler

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Intra-Operative Hemostatic Intervention	Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or 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, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours
Secondary	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 SOC or 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 Followup

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