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

Completed · Not applicable

Conditions studied: Excision of Kidney

In brief

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

Key facts

Study ID

NCT02807376

Run by

Ethicon Endo-Surgery

People needed

270

Starts

2016-07-05

Expected to finish

2017-08-23

Last updated by the study team

2018-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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