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NOT YET RECRUITING
NCT07197840

The CHALLENGER Registry

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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

Interventions

DEVICE

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