Radiation Dose of Pediatric Patients During Ureteroscopy

Urolithiasis Clinical Trial

Official title:

Radiation Doses of Pediatric Patients During Ureteroscopy and Percutaneous Nephrolithotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02895711
• Other study ID #: PRO10040374
• Status: Completed
• Start date: September 2010
• Est. completion date: December 2020

Study information

• Verified date: December 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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:

• None

Related Conditions & MeSH terms

• Urolithiasis

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposed to fluoroscopic radiation	To record the effective radiation dose to the patient during endourologic procedures to treat urolithiasis	through study completion, an average of 1 year