Recruiting

Numen SILK Coils

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07197840

Conditions

Chronic Subdural Hematoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Numen SILK coil embolization system

Study Details

Brief 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.

Conditions

Chronic Subdural Hematoma

Study ID

NCT07197840

Start date

Nov 20, 2025

Status verified date

Mar, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Numen SILK

Patients treated with the Numen SILK coil embolization system

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

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 and Locations

Central contacts

Sukaina Davdani

(212) 241-2524Sukaina.Davdani@mountsinai.org

Samantha St Elin

(212) 241-2524Samantha.StElin@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Sukaina Davdani

(212) 241-2524Sukaina.Davdani@mountsinai.org

Samantha St Elin

(212) 241-2524Samantha.StElin@mountsinai.org

Principal Investigator:

Daryl Goldman

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 28, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-07-28.