Stereotactic, Robot-assisted Intracerebral Hemorrhage Clot Evacuation

July 16, 2021 updated by: Zimmer Biomet

ROSA Stereotactic Robot-assisted Intracerebral Hemorrhage Clot Evacuation

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Stroke Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intracerebral hemorrhage
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
Image guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage
Other Names:
  • Stereotactic catheter placement
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.
Other Names:
  • ROSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma volume reduction
Time Frame: Day 1 to Day 4 post operative
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
Time Frame: Day 0
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
Time Frame: Baseline, 3-month, 6-month and 1-year post-operative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

University of Pittsburgh Medical Center

Investigators

  • Study Chair: Oscar Gonzalez, MD, DNP, Zimmer Biomet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2020

Primary Completion (ACTUAL)

September 30, 2020

Study Completion (ACTUAL)

September 30, 2020

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (ACTUAL)

January 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 16, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0717-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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