Non-Small Cell Lung CancerNCT03056300

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

A study testing Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler in people with Non-Small Cell Lung Cancer, run by Ethicon, Inc. at 1 site in China.

Completed

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

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: 11 Jan 2017to 26 May 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 to 75 years
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 IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
Performance status 0-1 (Eastern Cooperative Oncology Group classification);
ASA score < 3;
No prior history of VATS 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
18-75 years of age (inclusive).

Who cannot join

Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
Uncontrolled diabetes mellitus;
End stage renal or liver disease;
History of severe cardiovascular disease;
FEV1% <50% or severe COPD;

Show all 14Show fewer

Prior chemotherapy or radiation for lung cancer;
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);
Robotic-assisted procedure;
Women who are pregnant or lactating at the time of screening;
Physical or psychological condition which would impair study participation;
The subject is judged unsuitable for study participation by the Investigator for any other reason;
Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or
Unable or unwilling to attend follow-up visits and examinations.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Cancer Hospital
Beijing

Other trials in China

About this study

Conditions: Non-Small Cell Lung Cancer
Being tested: Video-Assisted Thoracoscopic Lobectomy with 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.

Video-Assisted Thoracoscopic Lobectomy with powered vascular staplerDevice
Powered Vascular Stapler used on vessels

Study groups in NCT03056300
Study group	Role	What they receive
Powered vascular stapler	Experimental	Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler Receives: Device: Video-Assisted Thoracoscopic Lobectomy with 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 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).
Measured: Intra-Operative
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).
Measured: Post-op through 4 week follow-up

Timeline

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

11 Jan 201726 May 2017

First posted17 Feb 2017
Study start11 Jan 2017
Primary completion26 May 2017
Study completion26 May 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03056300
Sponsor's protocol ID: ESC-14-006
Status last verified: Jan 2019
First submitted: 26 Jan 2017
Last updated: 30 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

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

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

All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies
ClinicalTrials.gov ID: NCT03056300
Acronym / sponsor ID: ESC-14-006
Conditions: Non-Small Cell Lung Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Ethicon, Inc.Industry (pharma, biotech, devices)
Study start: 11 Jan 2017 (actual)
Primary completion: 26 May 2017 (actual)
Study completion: 26 May 2017 (actual)
First posted: 17 Feb 2017 (actual)
Results: Posted 17 Dec 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Powered vascular stapler	Experimental	Device: Video-Assisted Thoracoscopic Lobectomy with powered vascular staplerVideo-Assisted Thoracoscopic Lobectomy with powered vascular stapler

Who may qualify

Ages: 18 to 75 years
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 IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7;
Subjects scheduled for VATS lobectomy in accordance with their institution's SOC;
Performance status 0-1 (Eastern Cooperative Oncology Group classification);
ASA score < 3;
No prior history of VATS or open lung surgery (on the lung in which the procedure will be performed);

Key exclusion criteria (14 listed)

Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure);
Uncontrolled diabetes mellitus;
End stage renal or liver disease;
History of severe cardiovascular disease;

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

Primary outcome

Incidence of Intra-Operative Hemostatic Interventions
Time frame: Intra-Operative
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).
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
Time frame: Post-op through 4 week follow-up
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).

Results and safety

Results posted to the registry on 17 Dec 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
Powered Vascular Stapler	50	47

Primary outcome: Incidence of Intra-Operative Hemostatic Interventions

Time frame: Intra-Operative. Number (95% Confidence Interval). Unit: Percentage of vessel transections

Measure	Powered Vascular Stapler n = 50
Value	1.8 (0.4 to 5.2)

Population analysed: All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions

Primary outcome: Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding

Time frame: Post-op through 4 week follow-up. Number (95% Confidence Interval). Unit: Percentage

Measure	Powered Vascular Stapler n = 50
Value	0 (0.0 to 7.1)

Population analysed: All enrolled subjects in whom a procedure was started.

Adverse events

Time frame: Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Powered Vascular Stapler	5 of 50 (10%)	12 of 50 (24%)	0 of 50

Limitations and caveats (from the sponsor): This was a single arm study with a limited sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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.

Keneng Chen principal investigator

Peking University Cancer Hospital & Institute

Shugeng Gao principal investigator

Cancer Institute and Hospital, Chinese Academy of Medical Services

Hu Jian principal investigator

The first affiliated hospital Zhejiang University/Hangzhou

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

Questions about this trial

What is this clinical trial studying?

A study testing Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler in people with Non-Small Cell Lung Cancer, run by Ethicon, Inc. at 1 site in China.

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 14 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 30 Jan 2019. 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 China. 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 17 Dec 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 Interventions (time frame: Intra-Operative). The study lists 2 primary outcomes in all. 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 NCT03056300.

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 30 Jan 2019.