Intracerebral HemorrhageNOTICENCT07246473
Non-invasive Ultrasound and Hematoma Clearance After Intracerebral Hemorrhage
A study testing non-invasive ultrasonic scalpel in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- non-invasive ultrasonic scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 3 sitesChina
- Study dates
- 12 Dec 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years;
- Spontaneous intracerebral hemorrhage (ICH);
- Supratentorial ICH;
- Hematoma volume <30 mL (calculated using the ABC/2 method);
- Glasgow Coma Scale (GCS) score >9 at randomization;
- Time from onset to randomization: 48-72 hours;
- Patient and/or legal representative provides informed consent.
Who cannot join
- Intracerebral hemorrhage attributed to other causes (e.g., cerebral aneurysm, cerebrovascular malformation, brain tumor, cerebral venous sinus thrombosis, hemorrhagic transformation of ischemic stroke, head trauma, anticoagulation therapy, hematologic disorders).
- Hemorrhage located in the infratentorial region.
- Hemorrhage confined primarily to the ventricular system.
- Clinical signs or symptoms suggestive of brain herniation (e.g., progressive decline in level of consciousness, diminished or absent pupillary light reflexes, bilateral pyramidal signs).
- Severe cardiac dysfunction (NYHA Class III or IV).
- High-risk chronic arrhythmias (e.g., sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia-related syncope without pacemaker implantation).
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- Severe hepatic impairment defined as ALT >2x ULN or AST >2x ULN (ULN = Upper Limit of Normal).
- Severe renal impairment defined as serum creatinine >1.5x ULN.
- History of severe asthma or chronic obstructive pulmonary disease (COPD).
- History of coagulopathy or systemic bleeding disorder.
- Leukopenia (<2 × 10⁹/L) or thrombocytopenia (<100 × 10⁹/L).
- Patients scheduled for surgical intervention (including, but not limited to, hematoma evacuation [minimally invasive or conventional], decompressive craniectomy, hematoma aspiration, or external ventricular drainage) prior to the first dose of study treatment.
- Pre-stroke modified Rankin Scale (mRS) score >2.
- Presence of other severe disease resulting in a life expectancy of less than 1 year.
- Inability to understand the study procedures and/or complete follow-up due to psychiatric illness, cognitive impairment, or emotional disorders.
- Women who are pregnant or lactating.
- Participation in another clinical trial within the past 3 months or current participation in another clinical trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Fengtai You'anmen Hospital
Beijing, Beijing Municipality
Yu Gao, 86 18201558843, gaoyu6181010@163.com
- Recruiting
Beijing Tiantan Hospital of Capital Medical University
Beijing, Beijing Municipality
Ruijun ji, 86 10 59975698, JRJchina@sina.com
- Not yet recruiting
The First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui
Xiangxiang Peng, 86 17856419920, pengxx0618@163.com
About this study
Official title: Study on the Safety and Efficacy of Non-Invasive Transcranial Doppler Ultrasound in Promoting Hematoma Clearance for Intracerebral Hemorrhage
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.
Read the 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
- Being tested
- non-invasive ultrasonic scalpel, Sham Comparator
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ultrasonic scalpelDevice
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 ComparatorDevice
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 group | Role | What they receive |
|---|---|---|
| Ultrasound Intervention Group | Experimental | 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. Receives: Device: non-invasive ultrasonic scalpel |
| Sham Comparator | 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 Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma clearance rate on CT at 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%.
Measured: Day 7±1day after randomization/discharge
Secondary outcomes (8)
Hematoma expansion on CT at 24±12 hours after randomization
A relative increase in hematoma volume ≥ 33%, calculated as: (Follow-up volume - Baseline volume) / Baseline volume ≥ 33%; OR An absolute increase in hematoma volume ≥ 12.5 mL, calculated as: Follow-up volume - Baseline volume ≥ 12.5 mL；
Measured: 24±12 hours after randomization
Neurological improvement at 24±12 hours after randomization (NIHSS(baseline)- NIHSS(24±12 hours))
Neurological status as assessed by the National Institutes of Health Stroke Scale (NIHSS) score； The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scale ranges from 0 to 42, where a higher score indicates more severe neurological deficit.
Measured: 24±12 hours after randomization
Absolute hematoma volume (mL) on CT at 72±12 hours after randomization
Measured: 72±12 hours after randomization
Neurological improvement at 72±12 hours after randomization(NIHSS(baseline)- NIHSS(72±12 hours))
Neurological status as assessed by the National Institutes of Health Stroke Scale (NIHSS) score； The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scale ranges from 0 to 42, where a higher score indicates more severe neurological deficit.
Measured: 72±12 hours after randomization
Absolute hematoma volume (mL) on CT at Day 7±1day after randomization/discharge
Measured: Day 7±1 day after randomization or discharge
Absolute perihematomal edema (PHE) volume (mL) on CT at Day 7±1day after randomization/discharge
Measured: Day 7±1 day after randomization or discharge
Neurological improvement at Day 7±1day after randomization/discharge(NIHSS(baseline)- NIHSS( Day 7±1day))
Neurological status as assessed by the National Institutes of Health Stroke Scale (NIHSS) score； The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The scale ranges from 0 to 42, where a higher score indicates more severe neurological deficit.
Measured: Day7±1day after randomization or discharge
Modified Rankin Scale (mRS) score at 90±7 days after onset
The modified Rankin Scale (mRS) is a standardized measure of global functional outcome and degree of disability or dependence after a stroke or other neurological disorder. It is a 7-point scale ranging from 0 to 6, with specific criteria for each grade:
0 - No symptoms at all.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead. A lower score indicates a better functional outcome.
Measured: 90±7 days after onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start12 Dec 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruijun Ji, Beijing Tiantan Hospital
- Investigators
- Ruijun Ji, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246473
- Sponsor's protocol ID
- CFH-brain2024-2-2051
- Acronym
- NOTICE
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of Non-Invasive Transcranial Doppler Ultrasound in Promoting Hematoma Clearance for Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT07246473
- Acronym / sponsor ID
- NOTICE / CFH-brain2024-2-2051
- Conditions
- Intracerebral Hemorrhage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Intervention Group | Experimental | Device: non-invasive ultrasonic scalpelOn 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 | Sham comparator | Device: Sham ComparatorOn 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 80 years;
- Spontaneous intracerebral hemorrhage (ICH);
- Supratentorial ICH;
- Hematoma volume <30 mL (calculated using the ABC/2 method);
- Glasgow Coma Scale (GCS) score >9 at randomization;
Key exclusion criteria (17 listed)
- Intracerebral hemorrhage attributed to other causes (e.g., cerebral aneurysm, cerebrovascular malformation, brain tumor, cerebral venous sinus thrombosis, hemorrhagic transformation of ischemic stroke, head trauma, anticoagulation therapy, hematologic disorders).
- Hemorrhage located in the infratentorial region.
- Hemorrhage confined primarily to the ventricular system.
- Clinical signs or symptoms suggestive of brain herniation (e.g., progressive decline in level of consciousness, diminished or absent pupillary light reflexes, bilateral pyramidal signs).
- Severe cardiac dysfunction (NYHA Class III or IV).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive ultrasonic scalpelOn 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 | Ultrasound Intervention Group |
| Sham ComparatorOn 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 | Device | Sham Comparator |
Primary outcome
Hematoma clearance rate on CT at Day 7±1day after randomization/discharge；
Time frame: 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%.
8 secondary outcomes
Hematoma expansion on CT at 24±12 hours after randomization
Time frame: 24±12 hours after randomization
Neurological improvement at 24±12 hours after randomization (NIHSS(baseline)- NIHSS(24±12 hours))
Time frame: 24±12 hours after randomization
Absolute hematoma volume (mL) on CT at 72±12 hours after randomization
Time frame: 72±12 hours after randomization
Neurological improvement at 72±12 hours after randomization(NIHSS(baseline)- NIHSS(72±12 hours))
Time frame: 72±12 hours after randomization
Absolute hematoma volume (mL) on CT at Day 7±1day after randomization/discharge
Time frame: Day 7±1 day after randomization or discharge
Absolute perihematomal edema (PHE) volume (mL) on CT at Day 7±1day after randomization/discharge
Time frame: Day 7±1 day after randomization or discharge
Neurological improvement at Day 7±1day after randomization/discharge(NIHSS(baseline)- NIHSS( Day 7±1day))
Time frame: Day7±1day after randomization or discharge
Modified Rankin Scale (mRS) score at 90±7 days after onset
Time frame: 90±7 days after onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruijun Ji principal investigator
Beijing Tiantan Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ultrasonic scalpel in people with Intracerebral Hemorrhage, run by Beijing Tiantan Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruijun Ji (86 10 5997 5698, JRJchina@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma clearance rate on CT at Day 7±1day after randomization/discharge； (time frame: Day 7±1day after randomization/discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.