18 and older, any sex, with Excision of Kidney. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Vessels Transected Requiring Intra-Operative Hemostatic InterventionsPrimary· Intra-Operative, an average of 2.6 hours, ranging from 42 minutes to 6.4 hours
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
Group
Value
95% CI
Standard of Care
0.1359
0.0977 – 0.1741
Powered Vascular Stapler
0.1836
0.1402 – 0.2271
Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein BleedingSecondary· Post-Op through 4 Week Follow-up
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).
Group
Value
95% CI
Standard of Care
0.0144
0.0 – 0.0342
Powered Vascular Stapler
0.0076
0.0 – 0.0225
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 Weeks Post Procedure.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Other trials of Surgeon's 'standard of care' stapler
Trials testing the same drug.
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· NA
· completed
Other Ethicon Endo-Surgery trials
Trials by the same sponsor.
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NCT05067647 — A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (E
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· NA
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ethicon Endo-Surgery
Last refreshed: 19 December 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02807376.