N/A
N=270
An Evaluation of a Powered Vascular Stapler in Laparoscopic Nephrectomies and Nephroureterectomies
Excision of Kidney
Bottom Line
View on ClinicalTrials.gov: NCT02807376 ↗Enrolled (actual)
270
Serious AEs
13.0%
Results posted
Dec 2018
Primary outcome: Primary: Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions — 0.1359; 0.1836 proportion of transected vessels
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surgeon's 'standard of care' stapler (Device); Ethicon Powered Vascular Stapler (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ethicon Endo-Surgery
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Vessels Transected Requiring Intra-Operative Hemostatic Interventions |
0.1359; 0.1836 | — |
| SECONDARY Proportion of Participants Requiring Post-operative Interventions or Procedures Related to Renal Artery or Renal Vein Bleeding |
0.0144; 0.0076 | — |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02807376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.