NCT07246473

Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage

Study on the Safety and Efficacy of Non-Invasive Transcranial Doppler Ultrasound in Promoting Hematoma Clearance for Intracerebral Hemorrhage

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blind, controlled trial investigating the use of a 2MHz non-invasive ultrasonic scalpel (ultrasound Doppler flow analyzer, registered as Medical System for Ultrasound Diagnosis) in patients with acute ICH. Eligible participants (n=86 will be randomized 1:1 to either the intervention group (ultrasound + standard medical treatment) or the control group (sham ultrasound + standard treatment). The ultrasound intervention involves daily 20-minute sessions for 7 consecutive days. Primary outcomes include hematoma clearance rates and neurological function improvement, assessed via imaging and clinical scales at multiple time points (baseline, 24±12 hours, 72±12 hours, 7±1days/discharge, 3 months). Safety will be monitored through adverse event tracking, vital signs, and neurological examinations. Ethical approval has been obtained, and all participants will provide informed consent.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-12
• Primary completion: 2027-08-30
• Completion: 2027-12-31
• First posted: 2025-11-24
• Last updated: 2026-04-17

Locations

3 sites across 1 country: China