Status:
COMPLETED
CeVUS With Intravesical Administration of OPTISON TM (Trademark) in Children
Lead Sponsor:
Kassa Darge
Conditions:
Vesico-Ureteral Reflux
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Contrast enhanced Voiding Urosonography (ceVUS) is a radiation free, highly sensitive imaging modality for vesicoureteral reflux (VUR) and urethral imaging in children. It employs ultrasound technolog...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02204917
Start Date
July 1 2014
End Date
March 1 2017
Last Update
November 27 2018
Active Locations (1)
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1
Department of Radiology, the Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104