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Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy

NCT04556396 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2024-06-06

Study results available
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Summary

Percutaneous nephrolithotomy (PCNL) is a first-line treatment for kidney stones \>2cm. Frequently, patients require multiple procedures to address their stone burden. The decision to proceed with a second-look procedure is based on follow-up CT imaging, which is obtained postoperatively. In this study, we propose the use of a portable CT scan technology to obtain follow-up imaging while the patient is still under anesthesia for the initial procedure. The goal of this study is to determine whether this allows the surgeon to identify residual fragments and render the patient stone-free within a single anesthetic event.

Conditions

  • Nephrolithiasis

Interventions

DIAGNOSTIC_TEST

Cone beam CT

On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Kristin G Baldea, MD · Attending Physician

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2021-07-01
Completion
2022-05-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556396 on ClinicalTrials.gov