Coil treatment may offer brain bleed patients a Surgery-Free option
NCT ID NCT07197840
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Mar 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The patient population for this study will be comprised of up to 100 patients with chronic subdural hematoma (cSDH).
- Ages
-
18 to 98 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Age 18-98 years inclusively * Per CT of the head, (one of the following): * Unilateral convexity cSDH measuring at least 10 mm in thickness OR * Bilateral cSDH if only one side is considered for treatment and the contralateral side is asymptomatic and \< 5 mm in thickness. * cSDH at least 2/3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying cSDH * Qualifying baseline head CT performed within the 14 days prior to treatment * Patient or legally authorized representative agrees to be participated in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization Exclusion Criteria: * Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor * Bilateral cSDH with unknown origin of symptoms * Participants who underwent prior embolization of either MMA * Tentorial or interhemispheric SDH * mRS \>4 * On tranexamic acid * Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio \[INR\] \> 1.5 and/or platelet count \< 80109/L) * Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA ophthalmic artery anastomosis) * Known contraindications to angiography * Known intolerance to occlusion procedures * Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or coil embolization * Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization. * Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial/capillary/venous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization. * Patient has a known active systemic infection or sepsis * Patient is pregnant, planning to become pregnant, or lactating * Life expectancy of less than 6 months due to comorbid terminal conditions * Concurrent participation in another research protocol for investigation of an experimental therapy * Known or suspected to not be able to comply with the study protocol
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Chronic subdural hematoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- China builds national watchdog for brain blood vessel devices
- Blocking a scalp artery could replace surgery for bleeding on the brain
- Which embolic agent works best for brain bleeding? a trial aims to find out
- Can a tiny artery block stop brain bleeds from coming back?
- Can we predict frailty in serious illness? a large study investigates
- Brain bleed surgery: does the drill site matter?