Status:

UNKNOWN

Efficacy of Contrast Enhanced Voiding Urosonography for Urodynamic Studies

Lead Sponsor:

University of Virginia

Conditions:

Myelomeningocele

Neurogenic Bladder

Eligibility:

All Genders

Up to 18 years

Brief Summary

The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.

Detailed Description

Urodynamic studies routinely involve instillation of iohexol (OmnipaqueTM), a low osmolality contrast agent, into the bladder followed by fluoroscopic imaging to assess for reflux or variant anatomy o...

Eligibility Criteria

Inclusion

  • Age 0-17
  • Must have had prior urodynamic study at UVA

Exclusion

  • Pregnant women (self-reported)
  • Fetuses
  • Neonates
  • Prisoners
  • Subjects with preexisting cardiac conditions (such as CHF and ventricular arrhythmias)
  • Subjects with a known hypersensitivity to Lumason

Key Trial Info

Start Date :

March 2 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 2 2022

Estimated Enrollment :

105 Patients enrolled

Trial Details

Trial ID

NCT04738539

Start Date

March 2 2021

End Date

March 2 2022

Last Update

April 28 2021

Active Locations (1)

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1

University of Virginia

Charlottesville, Virginia, United States, 22911