Study identification

PURI

https://redirect.ema.europa.eu/resource/47474

EU PAS number

EUPAS30600

Study ID

47474

Official title and acronym

An Observational Study of SonoVue®/Lumason®-Enhanced Urosonography in Paediatric Subjects with Known or Suspected Vesicoureteral Reflux (VUS for evaluation of Paediatric VUR)

DARWIN EU® study

No

Study countries

Italy

Study description

SonoVue has been recently approved in the EU for use in ultrasonography of the excretory tract in paediatric patients from newborn to 18 years to detect vesicoureteral reflux. This is a post-authorization observational, retrospective, comparative, study in paediatric subjects assessed with SonoVue/Lumason-enhanced VUS (VUS group) or VCUG (VCUG group) for evaluation of known or suspected VUR, as part of their standard of care. Subjects will be enrolled at sites performing either VUS or VCUG for evaluation of VUR. Data will be collected for the initial assessment of VUR and patient management decision as well as for the follow-up period of at least 12 months after the baseline VUS/VCUG exam. A documented follow-up at 12 months ± 1 month will be performed after the exam and if not available an intermediate follow up (9, 6, 3 months) will be used.

Study status

Finalised

Contact details

MARTIN KRIX

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

BRACCO IMAGING SPA
Study protocol
Initial protocol

BIM-PTR-AC2955.17-VUR_EMA-B082689-7.0

English (893.58 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable