Trial Outcomes & Findings for A Prospective, Multi-Center Evaluation of a Powered Vascular Stapler in Video-Assisted Thoracoscopic Lobectomies (NCT NCT03056300)

Last Updated: 2019-01-30

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Intra-Operative

Results posted on

2019-01-30

Participant Flow

Recruitment occurred from January 2017 to April 2017 across 4 sites.

This was a single-arm study where all enrolled patients would have their surgery performed using the powered vascular stapler.

Participant milestones

Participant milestones
Measure	Powered Vascular Stapler All enrolled subjects who had surgery performed using the powered vascular stapler.
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Powered Vascular Stapler All enrolled subjects who had surgery performed using the powered vascular stapler.
Overall Study Surgical reason per study protocol	3

Baseline Characteristics

All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Powered Vascular Stapler n=50 Participants All enrolled subjects who had surgery performed using the powered vascular stapler.
Age, Continuous	59.2 years STANDARD_DEVIATION 8.2 • n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Sex: Female, Male Female	28 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Sex: Female, Male Male	22 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Race (NIH/OMB) Asian	50 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Race (NIH/OMB) White	0 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.
Region of Enrollment China	50 Participants n=5 Participants • All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions.

PRIMARY outcome

Timeframe: Intra-Operative

Population: All enrolled subjects who had a procedure completed and provided data on the number of surgical interventions

Outcome measures

Outcome measures
Measure	Powered Vascular Stapler n=167 Vessel Transections All enrolled subjects who had surgery performed using the powered vascular stapler.
Incidence of Intra-Operative Hemostatic Interventions	1.8 Percentage of vessel transections Interval 0.4 to 5.2

PRIMARY outcome

Timeframe: Post-op through 4 week follow-up

Population: All enrolled subjects in whom a procedure was started.

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).

Outcome measures

Outcome measures
Measure	Powered Vascular Stapler n=50 Participants All enrolled subjects who had surgery performed using the powered vascular stapler.
Post-operative Interventions or Procedures Related to Pulmonary Artery or Pulmonary Vein Bleeding	0 Percentage Interval 0.0 to 7.1

Adverse Events

Powered Vascular Stapler

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Powered Vascular Stapler n=50 participants at risk All enrolled subjects who had surgery performed using the powered vascular stapler.
Cardiac disorders Acute myocardial infarction	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Respiratory, thoracic and mediastinal disorders Chylothorax	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Respiratory, thoracic and mediastinal disorders Pneumothorax	4.0% 2/50 • Number of events 2 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.

Other adverse events

Other adverse events
Measure	Powered Vascular Stapler n=50 participants at risk All enrolled subjects who had surgery performed using the powered vascular stapler.
General disorders Pyrexia	10.0% 5/50 • Number of events 5 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Cardiac disorders Atrial fibrillation	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
General disorders Chest discomfort	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Injury, poisoning and procedural complications Wound complication	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Investigations Blood albumin decreased	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Metabolism and nutrition disorders Hyperglycaemia	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Psychiatric disorders Anxiety	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Respiratory, thoracic and mediastinal disorders Pulmonary air leakage	4.0% 2/50 • Number of events 2 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	2.0% 1/50 • Number of events 1 • Adverse events were collected from the time informed consent was signed through the final study visit which occurred approximately four weeks after the surgery was performed.

Additional Information

Michael Schwiers

Ethicon

Phone: 513-337-1172

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60