Non-Small Cell Lung Cancer
Conditions
Brief summary
The primary objective of this trial is to demonstrate the effectiveness of the powered vascular stapler for transection of the pulmonary artery (PA) and pulmonary vein (PV) during Video-Assisted Thoracoscopic Lobectomy.
Interventions
DEVICEVideo-Assisted Thoracoscopic Lobectomy with powered vascular stapler
Powered Vascular Stapler used on vessels
Sponsors
Ethicon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with a confirmed or suspected diagnosis of stage IA to stage IIB non-small cell lung cancer scheduled for lobectomy (Lung Cancer Staging per American Joint Committee on Cancer,7th Edition)7; 2. Subjects scheduled for VATS lobectomy in accordance with their institution's SOC; 3. Performance status 0-1 (Eastern Cooperative Oncology Group classification); 4. ASA score \< 3; 5. No prior history of VATS or open lung surgery (on the lung in which the procedure will be performed); 6. Willing to give consent and comply with study-related evaluation and treatment schedule; and 7. 18-75 years of age (inclusive).
Exclusion criteria
1. Active (subject currently receiving systemic treatment) bacterial infection or fungal infection; 2. Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids (within 30 days prior to study procedure); 3. Uncontrolled diabetes mellitus; 4. End stage renal or liver disease; 5. History of severe cardiovascular disease; 6. FEV1% \<50% or severe COPD; 7. Prior chemotherapy or radiation for lung cancer; 8. Scheduled concurrent surgical procedure other than diagnostic wedge resection followed by lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed); 9. Robotic-assisted procedure; 10. Women who are pregnant or lactating at the time of screening; 11. Physical or psychological condition which would impair study participation; 12. The subject is judged unsuitable for study participation by the Investigator for any other reason; 13. Participation in any other investigational drug (within 30 days or 5 half-lives of an investigational drug) or device study; or 14. Unable or unwilling to attend follow-up visits and examinations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Intra-Operative Hemostatic Interventions | Intra-Operative | Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open). |
| Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | Post-op through 4 week follow-up | Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection). |
Countries
China
Participant flow
Recruitment details
Recruitment occurred from January 2017 to April 2017 across 4 sites.
Pre-assignment details
This was a single-arm study where all enrolled patients would have their surgery performed using the powered vascular stapler.
Participants by arm
| Arm | Count |
|---|---|
| Powered Vascular Stapler All enrolled subjects who had surgery performed using the powered vascular stapler. | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Surgical reason per study protocol | 3 |
Baseline characteristics
| Characteristic | Powered Vascular Stapler |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 8.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 0 Participants |
| Region of Enrollment China | 50 Participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 12 / 50 |
| serious Total, serious adverse events | 5 / 50 |
Outcome results
Primary
Incidence of Intra-Operative Hemostatic Interventions
Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of powered vascular stapler (PVS) defined as bleeding detected and controlled intraoperatively (additional stapling, over-sewing, clip placement, compression, use of suture, sealant, and/or buttress, and/or use of energy); or bleeding that occurs intra-operatively requiring blood or blood product transfusion or an additional surgical procedure (e.g. conversion to open).
Time frame: Intra-Operative
Population: All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Powered Vascular Stapler | Incidence of Intra-Operative Hemostatic Interventions | 1.8 Percentage of vessel transections |
Primary
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding
Incidence of hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the PA and PV during VATS lobectomy with the use of PVS: * Hemostasis intervention: bleeding that occurs post-operatively requiring blood or blood product transfusion or an additional surgical procedure (related to PA and PV transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).
Time frame: Post-op through 4 week follow-up
Population: All enrolled subjects in whom a procedure was started.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Powered Vascular Stapler | Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding | 0 Percentage |