Office-based Percutaneous Ultrasound-guided Renal Biopsy

NCT ID: NCT02075684

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-01

Study Completion Date

2024-04-30

Brief Summary

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The purpose of this research study is to create a prospectively maintained, multicenter database of patients undergoing renal biopsy for renal masses performed percutaneously (through skin), via an 18 gauge biopsy needle (.048 inches). In this database, the investigators will collect and maintain the data from the biopsy procedure. This will allow us to evaluate our experience with this procedure as well as to participate in multi-institutional collaborative studies in the future. At University of California Irvine, the investigators routinely biopsy patients with renal masses under real-time ultrasound control. Percutaneous renal biopsy under ultrasound guidance is a routine procedure performed to diagnose renal mass histopathology. The safety and efficacy of this procedure has been well documented in the literature. The indications for percutaneous renal biopsy have expanded as there has been a substantial increase in the number of renal masses that are being diagnosed, and the acceptance of percutaneous biopsy continues to expand in parallel. The biopsy procedure is part of your normal standard of care and if not being done for this research project.

Detailed Description

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Conditions

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Renal Cortical Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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In-office, Percutaneous Renal Biopsy

Group Type OTHER

Renal Biopsy

Intervention Type PROCEDURE

Interventions

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Renal Biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Must be undergoing standard percutaneous renal biopsy
* Patients must be ≥18 years of age
* Must be able to understand and render voluntary, written informed consent

Exclusion Criteria

* Patients \<18 years of age
* Pregnant women
* Coagulopathy
* Active urinary tract infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Jaime Landman

Professor of Urology and Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Landman, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Health Department of Urology

Locations

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Universty of California Irvine Medical Center

Orange, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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20139312

Identifier Type: -

Identifier Source: org_study_id

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