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Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation

NCT02331719 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2024-10-03

No results posted yet for this study

Summary

Intracerebral hemorrhage (ICH) is the most severe form of stroke: early mortality is 40%, and 80%-of survivors are physically disabled with high rates of cognitive impairment and depression.

In an effort to address the issues with conventional treatments, a new integrated systematic approach has been developed. This approach utilizes an educational process where specific core competencies (pillars) of mapping, navigation, access, optics and automated resection have been integrated into a single standardized system to deliver targeted therapy for an individual patient based on location and patient factors. This system has demonstrated safety and efficacy in oncology patients and is also FDA approved for use in the ICH patient population as well.

This registry will collect data form multiple site that preform the MiSPACE procedure as part of clinical care. The intent of this registry is to collect data on the economic impact as well as clinical outcomes using the MiSPACE approach with the integrated technology in the early treatment of ICH.

Conditions

  • Cerebral Hemorrhage

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Amin B Kassam, MD · Wake Forest University Health Sciences

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-09-30
Completion
2017-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02331719 on ClinicalTrials.gov