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

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

NCT02807376

15-002

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)

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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