An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

Study Overview
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Brief Summary
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This prospective, randomized, controlled, multi-center study will collect and compare data from the surgeon's current standard of care stapler (for renal artery and renal vein transection) and powered vascular stapler

Official Title
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A Prospective, Randomized, Controlled, Multi-Center Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies

Conditions
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Excision of Kidney

Intervention / Treatment
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* Device: Surgeon's 'standard of care' stapler
* Device: Ethicon Powered Vascular Stapler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for a simple or radical laparoscopic nephrectomy or a laparoscopic nephroureterectomy in accordance with the institution's standard of care (SOC); Performance status 0-1 (Eastern Cooperative Oncology Group classification), if applicable; American Society of Anesthesiologists (ASA) score < 3; No prior history of partial or wedge nephrectomy (on the kidney in which the procedure will be performed); Willing to give consent and comply with study-related evaluation and treatment schedule; and At least 18 years of age Exclusion Criteria: Prior chemotherapy or radiation (within 30 days prior to the procedure or the duration of the subject's enrollment); Pregnancy; Physical or psychological condition which would impair study participation; or The subject is judged unsuitable for study participation by the Investigator for any other reason.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgeon's 'standard of care' stapler<br>Surgeon's standard of care stapler | Device: Surgeon's 'standard of care' stapler<br> <br> |
| Experimental: Ethicon Powered Vascular Stapler<br>Ethicon Powered Vascular Stapler | Device: Ethicon Powered Vascular Stapler<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions | 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). | Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding | 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). | Post-Op through 4 Week Follow-up |