Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage
NCT07246473 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86
Last updated 2026-04-17
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.
Conditions
- Intracerebral Hemorrhage
Interventions
- DEVICE
-
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.
- DEVICE
-
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
Sponsors & Collaborators
-
Beijing Tiantan Hospital
lead OTHER
Principal Investigators
-
Ruijun Ji · Beijing Tiantan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-12
- Primary Completion
- 2027-08-30
- Completion
- 2027-12-31
Countries
- China
Study Locations
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