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

NCT ID: NCT02807376

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-05

Study Completion Date

2017-08-23

Brief Summary

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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

Detailed Description

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Conditions

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Excision of Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgeon's 'standard of care' stapler

Surgeon's standard of care stapler

Group Type ACTIVE_COMPARATOR

Surgeon's 'standard of care' stapler

Intervention Type DEVICE

Ethicon Powered Vascular Stapler

Ethicon Powered Vascular Stapler

Group Type EXPERIMENTAL

Ethicon Powered Vascular Stapler

Intervention Type DEVICE

Interventions

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Surgeon's 'standard of care' stapler

Intervention Type DEVICE

Ethicon Powered Vascular Stapler

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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15-002

Identifier Type: -

Identifier Source: org_study_id