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Clinical trialNCT04720456RecruitingPhase 2Interventional

SHAPE of Portal Hypertension in Children

SponsorThomas Jefferson UniversityEnrollment120Hypertension, Portal
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • the Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Kassa Darge, MD, PhDKathleen M Loomes, MDRyne Didier, MDSudha A Anupindi, MDSusan J Back, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

SHAPE measurement using the ultrasound contrast agent LumasonSHAPE measurement using the ultrasound contrast agent Sonazoid
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
3 Nov 2021
Primary completion
31 Jul 2025
Completion
31 Aug 2025
Last update posted
11 Feb 2025
Registered enrollment
120
Registry id
NCT04720456

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.