NCT02702921

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 29, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

March 2, 2016

Results QC Date

March 29, 2018

Last Update Submit

October 10, 2018

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding

    Post-Op through 4 Week Followup

Study Arms (2)

Surgeon's 'standard of care' stapler

ACTIVE COMPARATOR

Surgeon's current standard of care stapler

Device: Surgeon's 'standard of care' stapler

Ethicon Powered Vascular Stapler

EXPERIMENTAL

Ethicon Powered Vascular Stapler

Device: Ethicon Powered Vascular Stapler

Interventions

Surgeon's 'standard of care' staplerDEVICE
Surgeon's 'standard of care' stapler
Ethicon Powered Vascular StaplerDEVICE
Ethicon Powered Vascular Stapler

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Jason Waggoner, PhD
Organization
Ethicon Endo Surgery
jwaggon1@its.jnj.com
+1 513.337.8310

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 9, 2016

Study Start

February 1, 2016

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

October 11, 2018

Results First Posted

June 29, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)