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CompletedNCT02075684Updated Mar 13, 2025

Office-based Percutaneous Ultrasound-guided Renal Biopsy

An interventional study of Renal Biopsy in Renal Cortical Neoplasms, sponsored by University of California, Irvine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by University of California, Irvine · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2013, registered Aug 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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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Conditions studied

  • Renal Cortical Neoplasms
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In context

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients \<18 years of age
  • Pregnant women
  • Coagulopathy
  • Active urinary tract infection
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    In-office, Percutaneous Renal Biopsy

    Procedure: Renal Biopsy

Interventions

  • ProcedureRenal Biopsy
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What researchers measure

Primary outcomes

  1. Tumor Characteristics

    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).

    Time frame: Baseline

Secondary outcomes

  1. Verbal analog pain scale

    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.

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

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Study locations

1 site
  • Universty of California Irvine Medical Center
    Orange, California 92868, United States
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References and documents

Related links

Individual participant data

Plan to share: No — We do not intend to release individual data to other researchers.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02075684
Lead sponsor
University of California, Irvine
Collaborators
University of Michigan, University of California, Los Angeles, Vanderbilt University
Responsible party
Jaime Landman (Professor of Urology and Radiology, University of California, Irvine) — Principal investigator
First posted
Mar 3, 2014
Start date
Apr 1, 2013
Primary completion
Apr 2024
Completion
Apr 2024
Last update
Mar 13, 2025

Study contacts

Jaime Landman, MD
principal investigator · UCI Health Department of Urology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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