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OpenTrials
Completed

NCT Number: NCT02075684

Office-based Percutaneous Ultrasound-guided Renal Biopsy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universty of California Irvine Medical Center

Orange, California, 92868, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Biopsy

Procedure

Primary outcomes

  1. Tumor Characteristics

    Time frame: Baseline

    Tumor characteristics will be recorded at Baseline (from preoperative imaging) using the R.E.N.A.L. Nephrometry scoring system which captures tumor radius (R), depth within renal parenchyma (E), nearness to collecting system (N), anterior/posterior location (A) and polarity (L).

Secondary outcomes

  1. Verbal analog pain scale

    Time frame: Baseline, 1 hour post procedure, and 3 days - 3 weeks post-procedure

    Preprocedural and postprocedure verbal analog pain scale. Verbal analog pain scale (0 to 10) will be recorded immediately after and 60 minutes after the procedure. Additional pain assessment will be performed at a follow-up visit 3 days to 3 weeks after the procedure.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • University of California, Los Angeles
  • University of Michigan
  • Vanderbilt University

Registry information

Important dates

Study start
2013
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2014
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.