Chronic Subdural Hematoma Embolization With Detachable Coils

Part of paid clinical trials in New York, New York.

Sponsor: Icahn School of Medicine at Mount Sinai
Study ID: NCT07291427
Status: Recruiting

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Conditions

Chronic Subdural Hemorrhage (cSDH)

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Balt coils: (Balt USA, LLC) — DEVICE
MMA embolization utilizing Balt Coils
MMA embolization — PROCEDURE
surgical or bedside evacuation pre or post-surgical debridement

Study Details

This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).

Key Dates

First listed: Dec 18, 2025
Start date: Jun 2, 2026
Status verified: Jul 2026
Primary completion: Sep 1, 2028
Completion: Sep 1, 2028

Study Design

Enrollment: 150 participants (estimated)

Arms

Arm: Participants with cSDH
All participants enrolled will be treated with the Balt coils. 1. MMA embolization: Utilize Balt Coils as stand-alone with or without other embolics treatment. 2. MMA embolization: Utilize Balt Coils in combination with or without embolics in surgical or bedside evacuation, such as: 1. MMA embolization in combination with Balt coils post-surgical debridement, or 2. MMA embolization using Balt coils alone, pre- or post-surgical debridement.

Primary Outcome Measure

Change in hematoma volume [ Time Frame: 180 days ]

Central Contacts

Sukaina Davdani
(212) 241-2524
[email protected]
Sydney Edwards
(212) 241-2524
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Mount Sinai Hospital	New York	New York	10029	Sukaina Davdani [email protected] Sydney Edwards [email protected] Christopher Kellner (PRINCIPAL_INVESTIGATOR)

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Mount Sinai Hospital· New York, NY