Lung Cancer
Conditions
Keywords
lung cancer, lobectomy, wedge resection
Brief 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 Thoracoscopic Surgery (VATS).
Interventions
DEVICEENDO GIA™ Stapler with TRI-STAPLE™ Technology
All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Prolonged Air Leaks | Day 30 | Defined as \> 5 days by the Society for Thoracic Surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Air Leaks | Day 30 | As recorded on the air leak log. |
| Duration of Air Leak | Day 30 | Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge. |
| Length of Hospital Stay | Approximately Day 6 | — |
| Duration of Chest Tube Following Surgery | Approximately Day 5 | Chest tube duration was calculated as removal date - placement date + 1 |
| Incidence of Serosal Tearing | Day 30 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ENDO GIA™ Stapler With TRI-STAPLE™ Technology Single arm study, all patients will receive the study device. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | ENDO GIA™ Stapler With TRI-STAPLE™ Technology |
|---|---|
| Age, Continuous | 68.9 years STANDARD_DEVIATION 10.4 |
| Gender Female | 30 participants |
| Gender Male | 17 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 participants |
| Race (NIH/OMB) Asian | 2 participants |
| Race (NIH/OMB) Black or African American | 5 participants |
| Race (NIH/OMB) More than one race | 0 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants |
| Race (NIH/OMB) White | 40 participants |
| Region of Enrollment United States | 50 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 47 |
| serious Total, serious adverse events | 10 / 47 |
Outcome results
Primary
Incidence of Prolonged Air Leaks
Defined as \> 5 days by the Society for Thoracic Surgery
Time frame: Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ENDO GIA™ Stapler With TRI-STAPLE™ Technology | Incidence of Prolonged Air Leaks | 5 participants |
95% CI: [3.9, 21.3]
Secondary
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.
Time frame: Day 30
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ENDO GIA™ Stapler With TRI-STAPLE™ Technology | Duration of Air Leak | 3.52 days | Standard Deviation 4.42 |
Secondary
Duration of Chest Tube Following Surgery
Chest tube duration was calculated as removal date - placement date + 1
Time frame: Approximately Day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ENDO GIA™ Stapler With TRI-STAPLE™ Technology | Duration of Chest Tube Following Surgery | 5.02 days | Standard Deviation 4.54 |
Secondary
Incidence of Air Leaks
As recorded on the air leak log.
Time frame: Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ENDO GIA™ Stapler With TRI-STAPLE™ Technology | Incidence of Air Leaks | 33 number of patients with air leaks |
Secondary
Incidence of Serosal Tearing
Time frame: Day 30
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ENDO GIA™ Stapler With TRI-STAPLE™ Technology | Incidence of Serosal Tearing | 2 participants |
Secondary
Length of Hospital Stay
Time frame: Approximately Day 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ENDO GIA™ Stapler With TRI-STAPLE™ Technology | Length of Hospital Stay | 6.32 days | Standard Deviation 5.59 |