Non Small Cell Lung CancerNCT02702921

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

A study testing Ethicon Powered Vascular Stapler in people with Non Small Cell Lung Cancer, run by Ethicon Endo-Surgery at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer
What is being tested?: Ethicon Powered Vascular Stapler
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 201 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2016to 31 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory University
Atlanta, Georgia, 30322

Other trials in United States

About this study

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

Conditions: Non Small Cell Lung Cancer
Being tested: Surgeon's 'standard of care' stapler, Ethicon Powered Vascular Stapler
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Surgeon's 'standard of care' staplerDevice
Ethicon Powered Vascular StaplerDevice

Study groups in NCT02702921
Study group	Role	What they receive
Surgeon's 'standard of care' stapler	Active comparator	Surgeon's current standard of care stapler Receives: Device: Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler	Experimental	Ethicon Powered Vascular Stapler Receives: Device: Ethicon Powered Vascular Stapler

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
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).
Measured: Post-Op through 4 Week Followup

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201631 Mar 2017

First posted9 Mar 2016 (estimated)
Study start1 Feb 2016
Primary completion31 Mar 2017
Study completion31 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 201 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02702921
Sponsor's protocol ID: ESC-15-001
Status last verified: Oct 2018
First submitted: 2 Mar 2016
Last updated: 11 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in VAT Lobectomies
ClinicalTrials.gov ID: NCT02702921
Acronym / sponsor ID: ESC-15-001
Conditions: Non Small Cell Lung Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 201 participants (actual)
Lead sponsor: Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
Study start: 1 Feb 2016 (actual)
Primary completion: 31 Mar 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 9 Mar 2016 (estimated)
Results: Posted 29 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Surgeon's 'standard of care' stapler	Active comparator	Device: Surgeon's 'standard of care' staplerSurgeon's current standard of care stapler
Ethicon Powered Vascular Stapler	Experimental	Device: Ethicon Powered Vascular StaplerEthicon Powered Vascular Stapler

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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);

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Surgeon's 'standard of care' stapler	Device	Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler	Device	Ethicon Powered Vascular Stapler

Primary outcome

Incidence of Intra-Operative Hemostatic Intervention
Time frame: Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours
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).

1 secondary outcome

Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
Time frame: Post-Op through 4 Week Followup

Results and safety

Results posted to the registry on 29 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	98	84
Powered Vascular Stapler	103	95

Primary outcome: Incidence of Intra-Operative Hemostatic Intervention

Time frame: Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours. Number (95% Confidence Interval). Unit: Proportion transections w/ intervention

Measure	Standard of Care n = 98	Powered Vascular Stapler n = 103
Value	0.0533 (0.0279 to 0.0788)	0.0833 (0.0538 to 0.1129)

Population analysed: A total of 229 subjects were screened and 201 subjects were randomized into the study - 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS group. These subjects are included in the stapler group for the primary endpoint analysis, consistent with the intention-to-treat principle.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 Weeks Post Procedure. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	22 of 96 (22.9%)	35 of 96 (36.5%)	0 of 96
Powered Vascular Stapler	18 of 105 (17.1%)	33 of 105 (31.4%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Non Small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ethicon Powered Vascular Stapler in people with Non Small Cell Lung Cancer, run by Ethicon Endo-Surgery at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Intra-Operative Hemostatic Intervention (time frame: Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02702921.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.