Trial Outcomes & Findings for An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies (NCT NCT02807376)
NCT ID: NCT02807376
Last Updated: 2018-12-19
Results Overview
Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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).
COMPLETED
NA
270 participants
Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours
2018-12-19
Participant Flow
Recruitment was from July 2016 to July 2017 across 11 hospitals.
In total, 302 subjects were screened, 270 subjects were randomized, and those 32 subjects who were not randomized did not satisfy inclusion or exclusion criteria.
Participant milestones
| Measure |
Standard of Care
Facility's Current Instrumentation
|
Powered Vascular Stapler
Use of the ECHELON FLEX™ Powered Vascular Stapler
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
131
|
|
Overall Study
COMPLETED
|
136
|
130
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care
Facility's Current Instrumentation
|
Powered Vascular Stapler
Use of the ECHELON FLEX™ Powered Vascular Stapler
|
|---|---|---|
|
Overall Study
Intra-operative exclusion criteria
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
Baseline characteristics by cohort
| Measure |
Standard of Care
n=139 Participants
Facility's Current Instrumentation
|
Powered Vascular Stapler
n=131 Participants
Use of the ECHELON FLEX™ Powered Vascular Stapler
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.1 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
63.8 Years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
94 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
186 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
235 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hoursPopulation: All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection.
Proportion of hemostatic interventions/procedures completed for intra-operative bleeding related to the transection of the Reanl Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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).
Outcome measures
| Measure |
Standard of Care
n=309 Vessels Transected
Facility's Current Instrumentation
|
Powered Vascular Stapler
n=305 Vessels Transected
Use of the ECHELON FLEX™ Powered Vascular Stapler
|
|---|---|---|
|
Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions
|
0.1359 proportion of transected vessels
Interval 0.0977 to 0.1741
|
0.1836 proportion of transected vessels
Interval 0.1402 to 0.2271
|
SECONDARY outcome
Timeframe: Post-Op through 4 Week Follow-upPopulation: All randomized subjects in whom the Standard of Care or Powered Vascular Stapler was used for vessel transection.
Proportion of participants with hemostatic interventions /procedures completed for post-operative bleeding related to the transection of the Renal Artery and Renal Vein during laparoscopic nephrectomy or nephroureterectomy 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 Renal Artery and Renal Vein transection). No hemostasis intervention is defined as no interventions needed for post-operative bleeding (related to PA and PV transection).
Outcome measures
| Measure |
Standard of Care
n=139 Participants
Facility's Current Instrumentation
|
Powered Vascular Stapler
n=131 Participants
Use of the ECHELON FLEX™ Powered Vascular Stapler
|
|---|---|---|
|
Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding
|
0.0144 proportion of participants
Interval 0.0 to 0.0342
|
0.0076 proportion of participants
Interval 0.0 to 0.0225
|
Adverse Events
Standard of Care
Powered Vascular Stapler
Serious adverse events
| Measure |
Standard of Care
n=139 participants at risk
Facility's Current Instrumentation
|
Powered Vascular Stapler
n=131 participants at risk
Use of the ECHELON FLEX™ Powered Vascular Stapler
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
2/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Constipation
|
1.4%
2/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Ileus
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
General disorders
Chest pain
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
General disorders
Device occlusion
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
General disorders
Pain
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Abdominal sepsis
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Cellulitis
|
1.4%
2/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Lower respiratory tract infection
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Pneumonia
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Sepsis
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/139 • 4 Weeks Post Procedure
|
1.5%
2/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Urosepsis
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Wound infection
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Post procedural hemmorrhage
|
2.2%
3/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Post-operative ileus
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Investigations
Blood creatinine increased
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Renal and urinary disorders
Hematuria
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Reproductive system and breast disorders
Genital pain
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Surgical and medical procedures
Wound drainage
|
0.00%
0/139 • 4 Weeks Post Procedure
|
0.76%
1/131 • 4 Weeks Post Procedure
|
|
Vascular disorders
Hematoma
|
0.72%
1/139 • 4 Weeks Post Procedure
|
0.00%
0/131 • 4 Weeks Post Procedure
|
Other adverse events
| Measure |
Standard of Care
n=139 participants at risk
Facility's Current Instrumentation
|
Powered Vascular Stapler
n=131 participants at risk
Use of the ECHELON FLEX™ Powered Vascular Stapler
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.3%
6/139 • 4 Weeks Post Procedure
|
5.3%
7/131 • 4 Weeks Post Procedure
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
5/139 • 4 Weeks Post Procedure
|
8.4%
11/131 • 4 Weeks Post Procedure
|
|
General disorders
Pyrexia
|
3.6%
5/139 • 4 Weeks Post Procedure
|
4.6%
6/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Urinary tract infection
|
2.9%
4/139 • 4 Weeks Post Procedure
|
4.6%
6/131 • 4 Weeks Post Procedure
|
|
Infections and infestations
Wound infection
|
4.3%
6/139 • 4 Weeks Post Procedure
|
4.6%
6/131 • 4 Weeks Post Procedure
|
|
Renal and urinary disorders
Urinary retention
|
2.2%
3/139 • 4 Weeks Post Procedure
|
5.3%
7/131 • 4 Weeks Post Procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60