NCT02880878

ENRICH: Early MiNimally-invasive Removal of IntraCerebral Hemorrhage (ICH)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Nico Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 (i.e., 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 AHA/ASA 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 (i.e., 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 [phone], [e-mail] Sponsor - Backup: Jennifer Carroll, [phone], [e-mail]

Conditions

• Intracerebral Hemorrhage
• Cerebral Hemorrhage
• Intracerebral Haemorrhage

Interventions

Type	Name	Description
PROCEDURE	Early Surgical Hematoma Evacuation	Early Minimally Invasive Parafascicular Surgery (MIPS)

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-08-01
• Completion: 2023-02-01
• First posted: 2016-08-26
• Last updated: 2023-05-10

Locations

36 sites across 1 country: United States