Phase 2
Completed N=31
CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children
Vesico-Ureteral Reflux
Source: ClinicalTrials.gov NCT02204917 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: 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)
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.
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 | — |
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.
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. Informational only — not medical advice.