New York, NYNCT07197840Now EnrollingIRB Ready

Chronic Subdural Hematoma Clinical Trial in New York, NY

Access cutting-edge chronic subdural hematoma treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by Icahn School of Medicine at Mount Sinai

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Expert Care in New York

Access chronic subdural hematoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic subdural hematoma treatment provided free

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Check if you qualify for this chronic subdural hematoma clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Chronic Subdural Hematoma Study in New York

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.

Sponsor: Icahn School of Medicine at Mount Sinai

Who Can Participate

Inclusion Criteria

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
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

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
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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT07197840) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Subdural Hematoma Treatment Options in New York, NY

If you're searching for chronic subdural hematoma treatment options in New York, NY, this clinical trial (NCT07197840) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic subdural hematoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic subdural hematoma clinical trials near you to find additional studies recruiting in your area.

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