Non-small Cell Lung Cancer (NSCLC)NCT01808430
Powered Echelon Device in VATS Surgery
An observational study of Non-small Cell Lung Cancer (NSCLC), run by Ethicon Endo-Surgery (Europe) GmbH at 1 site in Denmark.
Trial summary
This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- VATS for confirmed non-small cell lung cancer (NSCLC)
- Type of treatment
- Surgery or procedure
- How many people
- 158 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2013to May 2014
- How long will I take part?
- 6 Weeks
- 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: Patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).
Who may be able to join
- Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
- Willing to give consent and comply with evaluation and treatment schedule
- At least 18 years of age
Who cannot join
- Active bacterial infection or fungal infection
- Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
- Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
- Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
- Prior history of VATS or open lung surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study
This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).
Read the detailed description
The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- VATS for confirmed non-small cell lung cancer (NSCLC)
- Keywords
- NSCLC
- 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.
VATS for confirmed non-small cell lung cancer (NSCLC)Procedure or surgery
Also called Video-Assisted Thoracoscopic Surgery
Video-Assisted Thoracoscopic Surgery for NSCLC patients
| Study group | Role | What they receive |
|---|---|---|
| VATS for NSCLC patients | VATS for confirmed non-small cell lung cancer (NSCLC) Receives: Procedure: VATS for confirmed non-small cell lung cancer (NSCLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence and duration of post-operative air leak
occurrence and duration of prolonged air leak defined as longer than 5 days
Measured: prolonged air leak defined as longer than 5 days post-op
Secondary outcomes (1)
volume of estimated intra-operative blood loss
volume of estimated intra-operative blood loss
Measured: blood loss intra-op and up to 5 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMay 2014
- Study completionMay 2014
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 Cancer (NSCLC)Studies 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
- 158 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery (Europe) GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Goran Ribaric, MD, MSc, PhD, Study chair, Ethicon Endo-Surgery (Europe) GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808430
- Sponsor's protocol ID
- CME-12-001
- Status last verified
- Feb 2015
- First submitted
- 6 Mar 2013
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Outcomes of Video-Assisted Thoracoscopic Surgery for Lung Cancer Using ECHELON FLEX™ Powered ENDOPATH® Stapler: a Prospective European Multicenter Study
- ClinicalTrials.gov ID
- NCT01808430
- Acronym / sponsor ID
- CME-12-001
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Ethicon Endo-Surgery (Europe) GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Mar 2013 (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 study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).
Detailed description
The European prospective observational multi-center cohort study aims to collect real-world outcomes of consecutive patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VATS for NSCLC patients | – | Procedure: VATS for confirmed non-small cell lung cancer (NSCLC)VATS for confirmed non-small cell lung cancer (NSCLC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for VATS lobectomy for histologically confirmed Non-Small Cell Lung Cancer (NSCLC) or scheduled for VATS wedge resection for undiagnosed pulmonary nodule or metastasis from colorectal cancer (CRC) in accordance with their institution's Standard-of-care (SOC).
Key inclusion criteria (4 listed)
- Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
- Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung
- Willing to give consent and comply with evaluation and treatment schedule
- At least 18 years of age
Key exclusion criteria (5 listed)
- Active bacterial infection or fungal infection
- Systemic administration (intravenous or oral) of steroids (within 30 days prior to study procedure)
- Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure
- Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g. port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
- Prior history of VATS or open lung surgery
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 |
|---|---|---|
| VATS for confirmed non-small cell lung cancer (NSCLC)Also: Video-Assisted Thoracoscopic SurgeryVideo-Assisted Thoracoscopic Surgery for NSCLC patients | Procedure or surgery | VATS for NSCLC patients |
Primary outcome
occurrence and duration of post-operative air leak
Time frame: prolonged air leak defined as longer than 5 days post-op
occurrence and duration of prolonged air leak defined as longer than 5 days
1 secondary outcome
volume of estimated intra-operative blood loss
Time frame: blood loss intra-op and up to 5 days post-op
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 12 Feb 2015.
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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.
Goran Ribaric, MD, MSc, PhD study chair
Ethicon Endo-Surgery (Europe) GmbH
1 site 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 (NSCLC), run by Ethicon Endo-Surgery (Europe) GmbH at 1 site in Denmark.
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 4 inclusion and 5 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 12 Feb 2015. 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 Denmark. 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 and duration of post-operative air leak (time frame: prolonged air leak defined as longer than 5 days post-op). 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 12 Feb 2015.