Robot arm takes on stroke complication in first human test
NCT ID NCT07641998
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether a robot can safely help remove blood clots in the brain that form after standard stroke treatments. About 20 adults who develop a specific type of bleeding will undergo a robot-assisted procedure to suction out the clot, followed by a clot-busting drug. The main goal is to see if the approach is safe and can reduce brain pressure without causing more bleeding.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: •. Age 18 years or older and younger than 80 years. * Prestroke modified Rankin Scale score of 0 to 2. * Acute ischemic stroke treated with reperfusion therapy (standard-dose intravenous thrombolysis using alteplase or tenecteplase, or mechanical thrombectomy or any other endovascular reperfusion procedure for the index stroke). * CT-confirmed symptomatic PH2 hemorrhagic transformation according to ECASS criteria in a supratentorial deep or lobar location, with hematoma-related mass effect and/or midline shift. * Hematoma volume 20 to 80 mL measured by ABC/2 method. * Neurological deterioration attributed to hemorrhagic transformation, defined as an NIHSS increase of 4 points or more from the best post-thrombolysis status or a GCS decrease of 2 points or more. * At least one repeat stability CT scan obtained 6 hours or more after the diagnostic CT showing no ongoing rapid expansion, defined as hematoma growth less than 6 mL. * Planned robot-assisted stereotactic minimally invasive puncture/aspiration within 24 hours after the diagnostic CT. * Completion of intravenous thrombolytic infusion at least 4 hours before final preprocedure assessment, with protocol-based reversal/correction of coagulopathy as needed. * Preprocedure coagulation thresholds achieved after reversal/correction: INR \< 1.4 or less, and fibrinogen \> 1.6 g/L. * Systolic blood pressure 180 mmHg or less maintained for at least 6 hours before the procedure. * Written informed consent provided by the participant or legally authorized representative. Exclusion Criteria: * HI1, HI2, or PH1 hemorrhagic transformation without clinically relevant mass effect. * Infratentorial hemorrhage, including brainstem or cerebellar hemorrhage. * Large malignant hemispheric infarction in which the dominant cause of mass effect is ischemic edema rather than hematoma, or clear need for decompressive craniectomy as first-line treatment. * Hemorrhage primarily attributable to aneurysm, arteriovenous malformation, dural arteriovenous fistula, moyamoya disease, tumor, trauma, or another structural lesion; or hemorrhage caused predominantly by a procedural vascular injury unrelated to thrombolysis-associated hemorrhagic transformation. * Intraventricular hemorrhage requiring separate emergency surgical treatment as the dominant lesion. * Irreversible brainstem failure, bilateral fixed and dilated pupils, or GCS score of 4 or less. * Ongoing hematoma expansion on stability CT, defined as growth of 6 mL or more. * Imaging evidence of active bleeding or markedly high rebleeding risk, such as spot sign, if judged unsafe for catheter aspiration. * Need for long-term anticoagulation that cannot be safely interrupted during the first 30 days after treatment. * No safe robot-planned stereotactic trajectory to the hematoma cavity. * Severe hepatic, renal, cardiac, respiratory, or hematologic illness likely to confound assessment or markedly increase procedural risk. * Pregnancy or breastfeeding. * Known allergy or hypersensitivity to alteplase or tenecteplase. * Participation in another interventional clinical trial. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China