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SHAPE of Portal Hypertension in Children

StatusCompleted
PhasePhase 2
Started
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Record History

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  1. Study completion date changed from estimate of Aug 2025 to Sep 8, 2026 Show 8 more changesShow less
    • Trial completed
    • Final enrollment: 12 participants (planned 120)
    • Primary completion date changed from estimate of Jul 2025 to Aug 31, 2025
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Site details revised
    • Collaborators: details revised at 1 of 2 entries
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Jul 2024 to Jul 2025
    • Study completion date: Aug 2024 to Aug 2025
    v7
  3. Primary completion date: Jul 2023 to Jul 2024
    • Study completion date: Aug 2023 to Aug 2024
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2021 to Nov 3, 2021
    • Site details revised
    v5
  5. Start date: Sep 2021 to Nov 2021v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: May 2021 to Sep 2021v3
  2. Start date: Jan 2021 to May 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04720456
Lead Sponsor Thomas Jefferson University
Collaborators: Children's Hospital of Philadelphia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Hypertension, Portal
Related terms Hypertension, Portal
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov