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

E

Ethicon

Status

Completed

Conditions

Excision of Kidney

Treatments

Device: Surgeon's 'standard of care' stapler
Device: Ethicon Powered Vascular Stapler

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

270 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

270 participants in 2 patient groups

Surgeon's 'standard of care' stapler
Active Comparator group
Description:
Surgeon's standard of care stapler
Treatment:
Device: Surgeon's 'standard of care' stapler
Ethicon Powered Vascular Stapler
Experimental group
Description:
Ethicon Powered Vascular Stapler
Treatment:
Device: Ethicon Powered Vascular Stapler

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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