Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02880878
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2016-08-18
Brief Title:
ENRICH Early MiNimally-invasive Removal of IntraCerebral Hemorrhage ICH
Sponsor:
Nico Corporation
Organization:
Nico Corporation
Study Overview
Official Title:
ENRICH A Multi-center Randomized Clinical Trial Comparing Standard Medical Management to Early Surgical Hematoma Evacuation Using Minimally Invasive Parafascicular Surgery MIPS in the Treatment of Intracerebral Hemorrhage ICH
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENRICH
Brief Summary:
This is a multicenter randomized adaptive clinical trial comparing standard medical management to early 24 hours surgical hematoma evacuation using minimally invasive parafascicular surgery MIPS in the treatment of acute spontaneous supratentorial intracerebral hemorrhage
Detailed Description:
The ENRICH trial will compare the outcomes between early surgical intervention using the BrainPath Approach ie MIPS and a medically managed cohort The integrated surgical approach includes a combination of available technologies including the FDA-cleared NICO BrainPath for non-disruptive access and NICO Myriad to achieve the goal of maximum clot evacuation The medically managed cohort will be treated according the Clinical Standardization Guidelines CSG as adapted by Emory University from the 2015 AHAASA Guidelines for the Management of Spontaneous Intracerebral Hemorrhage Clinical efficacy will be determined by demonstrating an improvement in functional outcome as determined by a blinded-assessment of the 180-day utility-weighted modified Rankin Scale mRS
Data suggests improved mortality rates and potential functional benefits of surgical ICH evacuation The methodology proposed for this trial was tested in a preliminary series of 39 patients treated for supratentorial spontaneous ICH and retrospectively reviewed Labib et al These results were replicated in a single center retrospective series of 18 patients Bauer et al Despite positive results of both studies and the widely accepted benefit of the BrainPath Approach ie MIPS for subcortical lesions stronger evidence supporting the use of these techniques in ICH is needed for the technique to become universally validated
CONTACTS
Sponsor - Primary Penny Sekerak MBA BA RN 317 569-1229 PennySekerakniconeurocom
Sponsor - Backup Jennifer Carroll 317 709-2466 JenniferCarrollniconeurocom
Data suggests improved mortality rates and potential functional benefits of surgical ICH evacuation The methodology proposed for this trial was tested in a preliminary series of 39 patients treated for supratentorial spontaneous ICH and retrospectively reviewed Labib et al These results were replicated in a single center retrospective series of 18 patients Bauer et al Despite positive results of both studies and the widely accepted benefit of the BrainPath Approach ie MIPS for subcortical lesions stronger evidence supporting the use of these techniques in ICH is needed for the technique to become universally validated
CONTACTS
Sponsor - Primary Penny Sekerak MBA BA RN 317 569-1229 PennySekerakniconeurocom
Sponsor - Backup Jennifer Carroll 317 709-2466 JenniferCarrollniconeurocom
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None