Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation

Intracerebral Hematoma Clinical Trial

Official title:

ROSA Stereotactic Robot-assisted Intracerebral Hemorrhage Clot Evacuation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03414307
• Other study ID #: 0717-1
• Status: Withdrawn
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2021
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hematoma
• Hemorrhage
• Intracerebral Hematoma

Intervention

Procedure:
• Intracerebral catheter placement
Image guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage

Device:
• Robot-assisted intracerebral catheter
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.

Locations

Country	Name	City	State
United States	UPMC Stroke Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hanley DF, Thompson RE, Muschelli J, Rosenblum M, McBee N, Lane K, Bistran-Hall AJ, Mayo SW, Keyl P, Gandhi D, Morgan TC, Ullman N, Mould WA, Carhuapoma JR, Kase C, Ziai W, Thompson CB, Yenokyan G, Huang E, Broaddus WC, Graham RS, Aldrich EF, Dodd R, Wijm — View Citation

Kim IS, Son BC, Lee SW, Sung JH, Hong JT. Comparison of frame-based and frameless stereotactic hematoma puncture and subsequent fibrinolytic therapy for the treatment of supratentorial deep seated spontaneous intracerebral hemorrhage. Minim Invasive Neuro — View Citation

Mendelow AD, Gregson BA, Rowan EN, Murray GD, Gholkar A, Mitchell PM; STICH II Investigators. Early surgery versus initial conservative treatment in patients with spontaneous supratentorial lobar intracerebral haematomas (STICH II): a randomised trial. La — View Citation

Vespa P, Hanley D, Betz J, Hoffer A, Engh J, Carter R, Nakaji P, Ogilvy C, Jallo J, Selman W, Bistran-Hall A, Lane K, McBee N, Saver J, Thompson RE, Martin N; ICES Investigators. ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surg — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma volume reduction	Percentage of hematoma evacuation identified by CT scan	Day 1 to Day 4 post operative
Secondary	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
Secondary	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