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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02786810
Other study ID # 1504311FB
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date November 2016

Study information

Verified date May 2016
Source University of Tennessee
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal ultrasound.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 50 Years
Eligibility Inclusion Criteria:

- Informed consent

- Age more than or equal to 8 years

- Patient with history of urinary tract infection (UTI) and history of Voiding Cystourethrogram (VCUG) for vesicoureteral reflux

- Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar

- Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast

Includes healthy volunteers

Exclusion Criteria:

- Age less than 8years

- Allergy to contrast or related products

- Cardiac shunt/ congenital heart anomalies

- Abnormal baseline ECG

- Open heart surgery

- Evidence of retinopathy

- Patient in intensive care

- Unable to comply with study requirement

- History of emphysema

- Unable to maintain oxygen saturation of 92% on at room air

- Pregnancy and lactation

Study Design


Intervention

Drug:
Sulfur hexafluoride type-a lipid microspheres
Used as a contrast to enhance renal ultrasound

Locations

Country Name City State
United States University of Tennessee Health Science Center Memphis Tennessee

Sponsors (1)

Lead Sponsor Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visualization of Renal Scars Compared to Previous Imaging The study will evaluate the contrast agent's ability to enable the ultrasound to produce adequate images of the kidneys as compared to the subject's previous renal imaging. This outcome will be measured in percentage of scars visualized by other imaging methods that were detected by using the contrast agent. 1 hour
Secondary Number of Participants With Adverse Events Related to the Study Drug. The study will evaluate how many people experience adverse events, specifically the two most common effects (headache and nausea), during the study or during the week following the study. 1 week
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