Phase 2 N=31 Diagnostic

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

Vesico-Ureteral Reflux

Bottom Line

View on ClinicalTrials.gov: NCT02204917 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG). — 50; 50; 2; 2 pelvic-ureteric units (PUUs)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: OPTISON (Drug)
Age: Pediatric, Adult
Sex: All
Sponsor: Kassa Darge
Primary completion: Mar 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Pelvic-ureter-units (PUUs) Detected With Vesicoureteral Reflux by Contrast Enhanced Voiding Urosonography (ceVUS) and by Voiding Cystourethrography (VCUG).	50; 50; 2; 2; 8; 6	—
PRIMARY Number of Participants With Adverse Events Following Contrast Enhanced Voiding Urosonography (ceVUS) With OPTISON and Voiding Cystourethrography (VCUG).	29; 1	—
SECONDARY Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children.	91.7; 98.0; 91.7; 98.0	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02204917). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.