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Clinical Trials/NCT02895711
NCT02895711
Completed
N/A

Radiation Doses of Pediatric Patients During Ureteroscopy and Percutaneous Nephrolithotomy

University of Pittsburgh1 site in 1 country126 target enrollmentSeptember 2010
ConditionsUrolithiasis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Urolithiasis
Sponsor
University of Pittsburgh
Enrollment
126
Locations
1
Primary Endpoint
Exposed to fluoroscopic radiation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to quantify the radiation exposure from diagnostic testing and surgical treatment during routine endourologic procedures for symptomatic urolithiasis.

Detailed Description

Routine endourologic procedures will be performed at the Childrens Hospital of Pittsburgh by one of the investigators listed on this study. Fluoroscopic radiation exposure during these procedures is used to guide the surgical devices that are used to treat the stones. The investigators will be measuring the radiation effective skin dose by two methods. First, the investigators will place two "Microdot" thermal leak detectors (TLD) on the patient. These devices which are the size and thickness of a dime will be within plastic bags taped to the patients body within the central focus of the fluoroscopy image. At the completion of the procedure the TLD's will be transferred to the Radiation Safety Office in Oakland to be read and the dose recorded. Second, a flat chamber that is integral with all fluoroscopy machines used at Children's Hospital will measure the dose-area product (DAP) for each case which will allow us to calculate the effective dose. This device is a component of the colimeter on the arm of the x-ray machine used for fluoroscopy. It measures the radiation that is returned to the x-ray machine and calculates the dose delivered to the patient by comparing the amount delivered to the patient to the amount returned to the machine. Its use is automatic when any x-rays are delivered and does not involve any manipulation of the patient or alteration of normal procedure. No additional procedures or change in duration is necessary for this study

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
December 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rajeev Chaudhry

Assistant Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Eligible subjects will be male and female volunteers of 0-18 years of age with documented urolithiasis who is undergoing a urologic procedure that utilizes fluoroscopy radiation.
  • The racial, gender and ethnic characteristics of the proposed subject population reflect the demographics of Pittsburgh and the surrounding area and/or the population of the University of Pittsburgh.
  • We shall attempt to recruit subjects in respective proportion to these demographics.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Exposed to fluoroscopic radiation

Time Frame: through study completion, an average of 1 year

To record the effective radiation dose to the patient during endourologic procedures to treat urolithiasis

Study Sites (1)

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