Non Small Cell Lung CancerNCT00912366
Assessment of Video Assisted Thoracoscopic Surgery (VATS) Versus Open Surgery for Patients Undergoing Lobectomy
An observational study of Non Small Cell Lung Cancer, run by Medtronic - MITG at 1 site in United States.
Trial summary
Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer. 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?
- Lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 2010
- 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: Subjects referred for lobectomies at the hospital.
Who may be able to join
- Subject must be 18 years of age or older.
- Subject must have been clinically diagnosed with stage I to stage IIA non small cell lung cancer measuring and judged to be resectable.
- Subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy
Who cannot join
- Subject is pregnant (documented by pregnancy test) or breastfeeding.
- Subject has other severe illnesses that would preclude surgery such as
- Unstable angina
- Myocardial Infarction within 3 months
- Coronary Artery Bypass Graft Surgery
- Subject has other active cancers
Show all 10Show fewer
- Subject is unable to comply with any of the following:
- Study requirements
- Give valid informed consent
- Follow-up schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Prospective, Single Center, Observational Study Comparing the Safety and Efficacy of CVATS, HVATS and Open Surgery for Subjects Diagnosed With NSCLC Scheduled to Undergo a Lobectomy
Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Lobectomy
- Keywords
- VATS, Lung cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LobectomyProcedure or surgery
Also called CVATS, HVATS
Assessment of VATS versus open surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group A | VATS Receives: Procedure: Lobectomy | |
| Group B | Open Surgery Receives: Procedure: Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess hospital length of stay (LOS).
Measured: 1 time point (discharge)
Pain Scale Evaluation
Measured: 5 time points out to 6 months
Secondary outcomes (2)
Assess quality of life.
Measured: 2 time points out to 6 months
Assess peri-operative and post-operative complications.
Measured: 5 time points out to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionDec 2010
Why it stopped: Slow Enrollment
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.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912366
- Sponsor's protocol ID
- AS08015
- Status last verified
- Jul 2015
- First submitted
- 1 Jun 2009
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Observational Study Comparing the Safety and Efficacy of CVATS, HVATS and Open Surgery for Subjects Diagnosed With NSCLC Scheduled to Undergo a Lobectomy
- ClinicalTrials.gov ID
- NCT00912366
- Acronym / sponsor ID
- AS08015
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- VATS, Lung cancer, NSCLC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow Enrollment
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Jun 2009 (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.
Assessment of VATS versus standard open surgery for treatment of non small cell lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: LobectomyVATS |
| Group B | – | Procedure: LobectomyOpen Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred for lobectomies at the hospital.
Key inclusion criteria (3 listed)
- Subject must be 18 years of age or older.
- Subject must have been clinically diagnosed with stage I to stage IIA non small cell lung cancer measuring and judged to be resectable.
- Subject must be able to tolerate general anesthesia, and have cardiopulmonary reserve to tolerate a lobectomy
Key exclusion criteria (10 listed)
- Subject is pregnant (documented by pregnancy test) or breastfeeding.
- Subject has other severe illnesses that would preclude surgery such as
- Subject has other active cancers
- Subject is unable to comply with any of the following:
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 |
|---|---|---|
| LobectomyAlso: CVATS, HVATSAssessment of VATS versus open surgery. | Procedure or surgery | Group A, Group B |
Primary outcome
Assess hospital length of stay (LOS).
Time frame: 1 time point (discharge)
Pain Scale Evaluation
Time frame: 5 time points out to 6 months
2 secondary outcomes
Assess quality of life.
Time frame: 2 time points out to 6 months
Assess peri-operative and post-operative complications.
Time frame: 5 time points out to 6 months.
Results and safety
The study was stopped early (reason given: Slow Enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 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.
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?
An observational study of Non Small Cell Lung Cancer, run by Medtronic - MITG 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 27 Jul 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 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?
The study was stopped early (reason given: Slow Enrollment). Results are not available in the source record.
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?
Assess hospital length of stay (LOS). (time frame: 1 time point (discharge)). 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?
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 27 Jul 2015.