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The CHALLENGER Registry
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
The study is a multi-center prospective, single-arm, post-market study evaluating the efficacy and radiologic and functional outcomes associated use of the Numen SILK coils for Middle Meningeal Artery (MMA) embolization following Chronic Subdural Hematoma (cSDH) compared to surgical evacuation or medical management alone. Chronic subdural hematoma is a collection of blood between the dural mater and the brain. It typically develops over time in older adults or people on anticoagulant medication. Blood slowly accumulates over time and often becomes encapsulated by a fibrous membrane over weeks or months, which can lead to the gradual development of symptoms. Middle Meningeal Artery embolization (MMAE) through coiling provides a minimally invasive option for cSDH treatment and prevention of reaccumulation and recurrence.
Official title: Chronic Subdural Hematoma Treated With Numen SILK Coiling of Middle Meningeal Artery
Key Details
Gender
All
Age Range
18 Years - 98 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-03-01
Completion Date
2028-03-01
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
Numen SILK coil embolization system
The Numen SILK coil embolization system is designed to be used in conjunction with the NumenFR detachment system. It consists of two main parts: • Introducer Sheath: The purpose of this sheath is to facilitate the introduction of the coil into the microcatheter. • Coil System: Composed of the pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. The NumenFR detachment system is a sterile, handheld, single-patient use device designed for use with the Numen SILK coil embolization system and is operated by two pre-loaded batteries
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States