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Comparative performance of ceVUS & VCUG for Vesicoureteral Reflux (ceVUS Trial)

Phase 1 & 2

Waitlist Available

Led By Kassa Darge, MD, PhD

Research Sponsored by Kassa Darge

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10-15 minutes.

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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.

Eligible Conditions

Vesicoureteral Reflux

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10-15 minutes.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10-15 minutes.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-15 minutes. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Urination

Vesico-Ureteral Reflux

Secondary study objectives

Compare the Diagnostic Accuracy of Contrast Enhanced Voiding Urosonography (ceVUS) With Voiding CystoUrethroGraphy (VCUG) for Vesicoureteral Reflux Detection and Urethral Imaging in Children.

Side effects data

From 2017 Phase 1 & 2 trial • 31 Patients • NCT02204917

Dysuria

100%

80%

60%

40%

20%

Study treatment Arm

ceVUS With the Use of OPTISON & VCUG in the Same Session

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Comparative performance of ceVUS & VCUGExperimental Treatment1 Intervention

Contrast enhanced Voiding Urosonography (ceVUS) will be performed with the intravesical administration of 0.1%-0.5% OPTISON / normal saline solution. The exact OPTISON dose (ml) that will be adjusted according to the age-related bladder filling capacity with a dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children. Voiding Cystourethrography (VCUG) exam will be subsequently performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perflutren

FDA approved

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