Lung CancerNCT01241565
ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
A study testing ENDO GIA™ Stapler with TRI-STAPLE™ Technology in people with Lung Cancer, run by Medtronic - MITG at 3 sites in United States.
Trial summary
The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- ENDO GIA™ Stapler with TRI-STAPLE™ Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Oct 2011
- 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
- The subject must be 18 years of age or older.
- The subject must be scheduled to undergo wedge resection or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer.
- The subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure.
- The subject must be willing and able to comply with all study requirements and have understood and signed the informed consent.
Who cannot join
- The subject is pregnant or breastfeeding.
- The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease.
- A rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. VATS procedures that are converted in the operating room to open procedures are not exclusionary.
- The subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected.
- The subject is scheduled to receive intra-operative brachytherapy.
- The subject has other severe illnesses that would preclude surgery such as unstable angina or myocardial infarction within 3 months.
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- Re-operative surgery is excluded if it is on the same side as the previous surgery.
- Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.
- The subject is unable to comply with the follow-up visit schedule
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cedar Sinai Medical Center
Los Angeles, California, 90048
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).
- Conditions
- Lung Cancer
- Being tested
- ENDO GIA™ Stapler with TRI-STAPLE™ Technology
- Keywords
- lung cancer, lobectomy, wedge resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO GIA™ Stapler with TRI-STAPLE™ TechnologyDevice
All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology
| Study group | Role | What they receive |
|---|---|---|
| ENDO GIA™ Stapler with TRI-STAPLE™ Technology | Experimental | Single arm study, all patients will receive the study device. Receives: Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Prolonged Air Leaks
Defined as > 5 days by the Society for Thoracic Surgery
Measured: Day 30
Secondary outcomes (5)
Incidence of Air Leaks
As recorded on the air leak log.
Measured: Day 30
Duration of Air Leak
Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.
Measured: Day 30
Length of Hospital Stay
Measured: Approximately Day 6
Duration of Chest Tube Following Surgery
Chest tube duration was calculated as removal date - placement date + 1
Measured: Approximately Day 5
Incidence of Serosal Tearing
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionOct 2011
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert McKenna, MD, Principal investigator, Cedar Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241565
- Sponsor's protocol ID
- COVEGTT0027
- Status last verified
- Jun 2014
- First submitted
- 18 Oct 2010
- Last updated
- 3 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
- ClinicalTrials.gov ID
- NCT01241565
- Acronym / sponsor ID
- COVEGTT0027
- Conditions
- Lung Cancer
- Keywords
- lung cancer, lobectomy, wedge resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Posted 3 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENDO GIA™ Stapler with TRI-STAPLE™ Technology | Experimental | Device: ENDO GIA™ Stapler with TRI-STAPLE™ TechnologySingle arm study, all patients will receive the study device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject must be 18 years of age or older.
- The subject must be scheduled to undergo wedge resection or lobectomy via Video Assisted Thoracoscopic Surgery (VATS) for a lung nodule suspicious for or clinically proven to be primary lung cancer.
- The subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate the procedure.
- The subject must be willing and able to comply with all study requirements and have understood and signed the informed consent.
Key exclusion criteria (9 listed)
- The subject is pregnant or breastfeeding.
- The subject is scheduled to undergo sleeve lobectomy, segmentectomy, bi-lobectomy, pneumonectomy or Lung Volume Reduction Surgery (LVRS), or lung biopsy for suspected interstitial lung disease.
- A rib-spreading thoracotomy incision is scheduled to be performed, however the use of an access incision without rib-spreading for specimen removal or to facilitate hilar dissection is allowed. VATS procedures that are converted in the operating room to open procedures are not exclusionary.
- The subject has received pre-operative chemotherapy or radiation therapy for the lung cancer that will be resected.
- The subject is scheduled to receive intra-operative brachytherapy.
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 |
|---|---|---|
| ENDO GIA™ Stapler with TRI-STAPLE™ TechnologyAll patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology | Device | ENDO GIA™ Stapler with TRI-STAPLE™ Technology |
Primary outcome
Incidence of Prolonged Air Leaks
Time frame: Day 30
Defined as > 5 days by the Society for Thoracic Surgery
5 secondary outcomes
Incidence of Air Leaks
Time frame: Day 30
Duration of Air Leak
Time frame: Day 30
Length of Hospital Stay
Time frame: Approximately Day 6
Duration of Chest Tube Following Surgery
Time frame: Approximately Day 5
Incidence of Serosal Tearing
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert McKenna, MD principal investigator
Cedar Sinai Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDO GIA™ Stapler with TRI-STAPLE™ Technology in people with Lung Cancer, run by Medtronic - MITG at 3 sites 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 4 inclusion and 9 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 3 Jul 2014. 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 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 3 Jul 2014). 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 Prolonged Air Leaks (time frame: Day 30). 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 3 Jul 2014.