Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation

Status: Completed
Location: See all (8) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Presented with acute symptomatic supratentorial primary ICH diagnosed by CT

• Has made the clinical treatment decision to have parafascicular minimally invasive subcortical (MIS) access to treat subcortical intracerebral hemorrhage (ICH) using the systems approach outlined in this protocol

• 18 - 80 years old

• Symptom onset to surgery \< 24 hours (target \< 8hours)

• Presurgical Glascow Coma Score ≥ 8

• Hematoma volume \< 60ml

• Minimal or no ventricular extension (corresponding to 50% or less of each ventricle)

Locations
United States
Arkansas
University Of Arkansas of Medical Sciences
Little Rock
Colorado
University of Colorado
Aurora
Georgia
Emory University at Grady Memorial Hospital
Atlanta
Illinois
OSF Saint Francis Medical Center
Peoria
Indiana
IU Health Neuroscience Center
Indianapolis
Missouri
St. Louis University
Saint Louis
Ohio
Riverside Methodist Hospital (OhioHealth)
Columbus
Wisconsin
Aurora Health Care, Aurora St. Luke's Medical Center
Milwaukee
Time Frame
Start Date: 2014-08
Completion Date: 2017-10
Participants
Target number of participants: 16
Treatments
MiSPACE Eligible Cohort
This will be a prospective record review of patients where the MiSPACE technique is being/was used for the treatment of their ICH.
Historical Cohort
This is a retrospective records review of patients who received either medical intervention or conventional surgical intervention for the treatment of their ICH.
Sponsors
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov