Coil treatment may offer brain bleed patients a Surgery-Free option

NCT ID NCT07197840

Recruiting now Disease control Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests a device called the Numen SILK coil, which is placed into the middle meningeal artery to block blood flow and help resolve chronic subdural hematoma—a slow brain bleed common in older adults. Researchers will enroll 100 people to see if this minimally invasive procedure reduces the need for rescue surgery or death within 180 days. The goal is to offer a less risky alternative to traditional brain surgery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Numen SILK coil embolization system (a device that blocks blood flow in the middle meningeal artery)
What this could lead to: If successful, this minimally invasive coil procedure could become a standard way to treat chronic subdural hematoma, reducing the need for brain surgery and lowering the chance of blood re-accumulation.
What could go wrong: This is a single-arm, post-market study with no comparison group, so results may be less definitive. The procedure carries risks such as bleeding, infection, or coil migration, and it may not work for all patients.

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHRONIC SUBDURAL HEMATOMA CHRONIC SUBDURAL HEMORRHAGE (CSDH)

Contacts and locations

Locations

Icahn School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029, United States

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