Non-small Cell Lung CancerNCT02338583
Powered Surgical Stapler in VATS Lung Resection Procedures in China
An observational study of Non-small Cell Lung Cancer, run by Ethicon Endo-Surgery at 3 sites in China.
Trial summary
This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). 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?
- Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 3 sitesChina
- Study dates
- 1 Dec 2014to 1 May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Individuals scheduled for VATS lobectomy or diagnostic VATS wedge resection in accordance with their institution's SOC
Who may be able to join
- Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
- Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- ASA score < 3;
- No prior history of VATS or open lung surgery;
- Willing to give consent and comply with study-related evaluation and treatment schedule; and
- At least 18 years of age.
Who cannot join
- Subjects satisfying the following criteria will be eligible for participation in this study:
- Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
- Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- ASA score < 3;
- No prior history of VATS or open lung surgery;
- Willing to give consent and comply with study-related evaluation and treatment schedule; and
- At least 18 years of age.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Cancer Hospital
Beijing
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing
Wuhan Tongji Hospital
Beijing
About this study
Official title: A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China
This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC), and who meet study entry criteria, may be enrolled.
Study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter
- 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.
Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear CutterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of prolonged air leaks
Measured: 30 days
Secondary outcomes (4)
2.Occurrence of postoperative air leaks
Measured: 30 days
Length of stay (LOS)
Measured: 30 days
Volume of estimated intra-operative blood loss
Measured: Intra-operative
5.Time to chest tube removal
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study start1 Dec 2014
- Primary completion1 Apr 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338583
- Sponsor's protocol ID
- ESC-14-003
- Status last verified
- Aug 2017
- First submitted
- 12 Jan 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: via publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China
- ClinicalTrials.gov ID
- NCT02338583
- Acronym / sponsor ID
- ESC-14-003
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC), and who meet study entry criteria, may be enrolled.
Study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals scheduled for VATS lobectomy or diagnostic VATS wedge resection in accordance with their institution's SOC
Key inclusion criteria (7 listed)
- Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
- Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- ASA score < 3;
- No prior history of VATS or open lung surgery;
Key exclusion criteria (8 listed)
- Subjects satisfying the following criteria will be eligible for participation in this study:
- Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
- Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- ASA score < 3;
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 |
|---|---|---|
| Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter | Device | – |
Primary outcome
Occurrence of prolonged air leaks
Time frame: 30 days
4 secondary outcomes
2.Occurrence of postoperative air leaks
Time frame: 30 days
Length of stay (LOS)
Time frame: 30 days
Volume of estimated intra-operative blood loss
Time frame: Intra-operative
5.Time to chest tube removal
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Individual participant dataSharing planned: Yes. via publication
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Ethicon Endo-Surgery at 3 sites 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 8 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 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of prolonged air leaks (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2017.