Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage
Condition(s) studied
Investigational drug(s) / intervention(s)
non-invasive ultrasonic scalpel: On the basis of best medical management, 2 MHz non-invasive ultrasonic scalpel was used for intervention within 48-72 hours after the occurrence of intracerebral hemorrhage, 20min/ day, and continued for 7 days.
Sham Comparator: On the basis of best medical management, a sham non-invasive ultrasonic scalpel (simulating real treatment with zero energy output) was applied within 48-72 hours after the occurrence of intracerebral hemorrhage, 20 min/day for 7 consecutive days
Study summary
Intracerebral hemorrhage (ICH) is one of the stroke subtypes with the highest global rates of disability and mortality, accounting for 15%-20% of all strokes. Currently, there is a lack of evidence-based interventions for ICH, with treatment primarily relying on supportive care. There is an urgent clinical need to explore new strategies and technologies. The investigators hypothesize that for ICH patients, best medical treatment combined with a non-invasive ultrasonic scalpel (ultrasound Doppler flow analyzer) may be superior to best medical treatment alone. The primary objective of this study is to determine the safety and efficacy of the non-invasive ultrasonic scalpel in promoting hematoma clearance in ICH patients.
Eligibility
Primary outcome measure(s)
- Hematoma clearance rate on CT at Day 7±1day after randomization/discharge; — Day 7±1day after randomization/discharge
Hematoma clearance rate is defined as the percentage reduction in intracerebral hematoma volume from baseline to the follow-up CT scan. It is calculated using the formula: \[(Baseline volume - Follow-up volume) / Baseline volume\] x 100%.
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical University | Wuhu | Anhui | Not Yet Recruiting |
| Beijing Fengtai You'anmen Hospital | Beijing | Beijing Municipality | Recruiting |
| Beijing Tiantan Hospital of Capital Medical University | Beijing | Beijing Municipality | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07246473 on ClinicalTrials.gov ↗ ← All trials in China