CompletedPhase 1/2

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

United States31 participantsStarted 2014-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG).

Timeframe: 10-15 minutes.

Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG).

Timeframe: Within 1 hour and up to 2 days after ceVUS and VCUG examinations completion.

Trial details

NCT IDNCT02204917

SponsorKassa Darge

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

Results submitted2017-07-19

View on ClinicalTrials.gov More Vesico-Ureteral Reflux trials