The CHALLENGER Registry

Conditions

• Chronic Subdural Hemorrhage (cSDH)

Eligibility Criteria

Sex

ALL

Age

18 Years - 98 Years

Healthy Volunteers

Not accepted

Interventions

• Numen SILK coil embolization system — DEVICE
  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

Study Details

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.

Key Dates

Start date

Mar 1, 2026

Status verified

Sep 2025

Primary completion

Mar 1, 2028

Completion

Mar 1, 2028

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: Numen SILK
  Patients treated with the Numen SILK coil embolization system

Primary Outcome Measure

Proportion of patients that need rescue surgery or die within 180 days of MMA coil embolization [ Time Frame: 180 days ]

Central Contacts

• Sukaina Davdani
  (212) 241-2524
  [email protected]
• Samantha St Elin
  (212) 241-2524
  [email protected]

Locations (1)

Find similar trials in New York, NY

Related Studies

• Chronic Subdural Hematoma Embolization With Detachable Coils
  Not Yet Recruiting · Icahn School of Medicine at Mount Sinai · New York, New York