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NCT02331719 · ClinicalTrials.gov registry record
Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 16
- Enrollment target
NCT02331719: Completed study, sponsored by Wake Forest University Health Sciences.
NCT02331719 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02331719 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 16 participants
- Enrollment target
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.
Primary Outcome
Overall surgical performance is a composite outcome measure that will be assessed by evaluating a number of events and outcomes. Data will be collected on any surgical complications (defined as peri-operative blood loss, thrombotic events, infections, neurological worsening, seizures, metabolic disturbances, and cardiopulmonary events, within 30 days of surgery). Data from re-admissions within the first 30 days will also be included. In addition, data regarding the duration of surgery, time to r
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-08 |
| Est. Completion | 2017-10 |
What the finished NCT02331719 record still lists
NCT02331719 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02331719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02331719 about?
NCT02331719 is a clinical study titled "Evaluation of Minimally Invasive Subcortical Parafascicular Access for Clot Evacuation". 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 be...
What is the current status of trial NCT02331719?
This trial is currently completed. The enrollment target is 16 participants. The study started on 2014-08. Estimated completion is 2017-10.
Who is sponsoring clinical trial NCT02331719?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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