CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children

Completed · Phase 1/Phase 2

Conditions studied: Vesico-Ureteral Reflux

In brief

In this clinical trial the investigators aim to evaluate the diagnostic feasibility and safety of ceVUS with the intravesical use of OPTISON for vesicoureteral reflux detection and urethral imaging in children.

Key facts

Study ID

NCT02204917

Run by

Kassa Darge

People needed

31

Starts

2014-07-01

Expected to finish

2017-03-01

Last updated by the study team

2018-11-27

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children 2-18 years (first age cohort).
• Children 0-18 years (second age cohort).
• Referred to the Children's Hospital of Philadelphia (CHOP) for the performance of the clinically indicated Voiding Cystourethrography (VCUG) examination.
• Parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of contrast enhanced Voiding Urosonography (ceVUS) examination.

You may not qualify if…

• Hypersensitivity to perflutren, blood, blood products or albumin.
• Children requiring sedation for VCUG or ceVUS examinations.
• Parents/guardians or subjects who, in the opinion of the principal investigator, may be non-compliant with study schedules or procedures.

Where it is running

• Department of Radiology, the Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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