Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation

Study Overview
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Brief Summary
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Non-traumatic intracerebral hemorrhage (ICH) affects approximately 100,000 Americans yearly. Up to 30-50% of ICH is fatal, and those patients who survive are often left with significant neurologic dysfunction. In the past, medical management (e.g., control of hypertension, reversal of antiplatelet or anticoagulants) had been the most effective treatment for these patients, given the morbidity and mortality associated with open surgical treatment for evacuation of ICH. However, recent trials have demonstrated that minimally invasive stereotactic neurosurgical procedures to evacuate ICH are safe and result in improved outcomes for these patients. Initial attempts to evaluate the efficacy of surgical evacuation of ICH found no significant difference between medical management and standard craniotomy for surgical evacuation. Indeed, open surgery was often discouraged for these patients due to the significant morbidity and mortality associated with the surgical procedure itself. However, research has demonstrated that minimally invasive, image guided stereotactic frame-based and frameless methods are effective and safe for the placement of catheters for clot aspiration and fibrinolytic therapy of ICH in the basal ganglia and other deep seated regions. Larger randomized controlled trials have demonstrated that these minimally invasive approaches also offer clinical benefit for these patients.

Detailed Description
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The introduction of the ROSA stereotactic robot offers an image guided stereotactic approach with greater precision and accuracy than traditional frame-based and frameless methods. While the ROSA has never been used for the placement of intra-hemorrhage catheters, prior applications such as brain biopsies and abscess drainage represent similar surgical procedures which require the same planning, precision, and surgical technique. At the very least, ROSA offers an accurate image guided approach to deep lesions that should be comparable to competitive image guided platforms. At best, ROSA offers superior trajectory planning software, greater ease in planning multiple trajectories to large, irregular clots, and the potential for robot aided navigation into and out of the hematoma which is the greatest source of human error in these cases. For instance, the procedure often requires advancement of a larger aspiration catheter, slow aspiration as the catheter is withdrawn, and then re-advancement of a smaller catheter into the hematoma, which is left in place. The ability to advance and remove catheters in a fixed trajectory with robotic assistance may represent the greatest advantage of ROSA.

Official Title
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ROSA Stereotactic Robot-assisted Intracerebral Hemorrhage Clot Evacuation

Conditions
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Intracerebral Hematoma

Intervention / Treatment
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* Procedure: Intracerebral catheter placement
* Device: Robot-assisted intracerebral catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-85 Head CT demonstrates an acute, spontaneous, supratentorial, primary ICH ICH volume ≥30 cc Surgery initiated within 48 hours of hospital admission Exclusion Criteria: Pregnancy at the time of surgery Underlying vascular lesion defined as causative source of ICH Irreversible coagulopathy Profound neurological deficit defined as fixed/dilated pupils, bilateral extensor motor posturing Infratentorial or brainstem ICH Known life expectancy <6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Subject enrolled serve as their own control to evaluate the effect of ROSA robotic-assisted intracerebral catheter placement.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracerebral hemorrhage<br>Patients with ICH meeting inclusion/exclusion criteria undergo ROSA stereotactic robot-assisted intracerebral catheter placement to evacuate intracerebral or intracranial hemorrhage | Procedure: Intracerebral catheter placement<br>* Image guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage<br>* Other names: Stereotactic catheter placement;Device: Robot-assisted intracerebral catheter<br>* ROSA is a robotic device with trajectory planning software that can be used to aid in planning multiple trajectories to large, irregular clots, and aids in navigating into and out of the cerebral hematoma with minimum human error.<br>* Other names: ROSA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematoma volume reduction | Percentage of hematoma evacuation identified by CT scan | Day 1 to Day 4 post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linear measurement of accuracy | Accuracy of catheter placement is assessed by comparing planned stereotactic trajectories to actual location of the intracerebral catheter. Measure of linear displacement is given in millimeters. | Day 0 | 
| Functional Outcomes measured by modified Rankin Scale (mRS) for neurologic disabilities | mRS evaluates in a scale 0-6 the degree of disability in patients who have suffered a cerebral stroke or hemorrhage. | Baseline, 3-month, 6-month and 1-year post-operative |