Trial Outcomes & Findings for Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies (NCT NCT02702921)

Last Updated: 2018-10-11

Results Overview

Incidence of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Pulmonary Artery and Pulmonary Vein during Video Assisted Thoracoscopic lobectomy with the use of standard of care stapler (SOC) or 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).

Recruitment status

COMPLETED

Study phase

Target enrollment

201 participants

Primary outcome timeframe

Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours

Results posted on

2018-10-11

Participant Flow

Recruitment was from Feb 2016 to Feb 2017 across 7 hospitals.

229 subjects signed an informed consent, 201 were randomized into one of the two groups. The 28 not randomized did not meet the inclusion criteria.

Participant milestones

Participant milestones
Measure	Standard of Care Facility's Current Instrumentation	Powered Vascular Stapler Use of the ECHELON FLEX™ Powered Vascular Stapler
Overall Study STARTED	98	103
Overall Study COMPLETED	84	95
Overall Study NOT COMPLETED	14	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Powered Vascular Stapler in Video-Assisted Thoracoscopic (VAT) Lobectomies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care n=98 Participants Facility's Current Instrumentation	Powered Vascular Stapler n=103 Participants Use of the ECHELON FLEX™ Powered Vascular Stapler	Total n=201 Participants Total of all reporting groups
Age, Continuous	68.2 Years STANDARD_DEVIATION 9.1 • n=5 Participants	68.0 Years STANDARD_DEVIATION 9.0 • n=7 Participants	68.0 Years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	60 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	43 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	70 Participants n=7 Participants	136 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	94 Participants n=5 Participants	98 Participants n=7 Participants	192 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Intra-Operative, an average of 2.3 hours, ranging from 30 mintues to 6.4 hours

Population: A total of 229 subjects were screened and 201 subjects were randomized into the study - 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS group. These subjects are included in the stapler group for the primary endpoint analysis, consistent with the intention-to-treat principle.

Outcome measures

Outcome measures
Measure	Standard of Care n=300 Vessels Transection Facility's Current Instrumentation	Powered Vascular Stapler n=336 Vessels Transection Use of the ECHELON FLEX™ Powered Vascular Stapler
Incidence of Intra-Operative Hemostatic Intervention	0.0533 Proportion transections w/ intervention Interval 0.0279 to 0.0788	0.0833 Proportion transections w/ intervention Interval 0.0538 to 0.1129

SECONDARY outcome

Timeframe: Post-Op through 4 Week Followup

Population: A total of 229 subjects were screened and 201 subjects were randomized into the study - 98 randomized to SOC and 103 randomized to PVS. Two subjects randomized to SOC stapler received the PVS stapler. These subjects are included in the PVS group for safety analysis.

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 SOC or 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).

Outcome measures

Outcome measures
Measure	Standard of Care n=96 Participant Facility's Current Instrumentation	Powered Vascular Stapler n=105 Participant Use of the ECHELON FLEX™ Powered Vascular Stapler
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding	0.0104 Proportion participants w/ intervention Interval 0.0 to 0.0307	0.0095 Proportion participants w/ intervention Interval 0.0 to 0.0281

Adverse Events

Standard of Care

Serious events: 22 serious events

Other events: 35 other events

Deaths: 0 deaths

Powered Vascular Stapler

Serious events: 18 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Standard of Care n=96 participants at risk Facility's Current Instrumentation	Powered Vascular Stapler n=105 participants at risk Use of the ECHELON FLEX™ Powered Vascular Stapler
Cardiac disorders Atrial fibrillation	4.2% 4/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	5.7% 6/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Gastrointestinal disorders Nausea	7.3% 7/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	5.7% 6/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Gastrointestinal disorders Vomiting	3.1% 3/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	0.95% 1/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
General disorders Pain	1.0% 1/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	3.8% 4/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Infections and infestations Pneumonia	5.2% 5/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	2.9% 3/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Infections and infestations Wound infection	4.2% 4/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	0.00% 0/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Injury, poisoning and procedural complications Arterial injury	3.1% 3/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	0.00% 0/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Injury, poisoning and procedural complications Wound secretion	0.00% 0/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	5.7% 6/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	5.2% 5/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	5.7% 6/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.
Skin and subcutaneous tissue disorders Pruritus	3.1% 3/96 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.	0.95% 1/105 • 4 Weeks Post Procedure For safety reporting, subjects are counted under the device that was actually used. For Participant Flow, Baseline and Outcome Measures, subjects are counted in their randomized group consistent with the intention-to-treat principle. Two subjects who were randomized to Standard of Care were operated on with the Powered Vascular Stapler (PVS), thus these 2 are counted in the PVS group for Adverse Event summaries, thus the difference in total number at risk when comparing to the Participant Flow.

Additional Information

Jason Waggoner, PhD

Ethicon Endo Surgery

Phone: +1 513.337.8310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60