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
Not Yet 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

Start date
Jul 1, 2026
Status verified
Mar 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

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Sukaina Davdani
[email protected]
Sydney Edwards
[email protected]
Christopher Kellner (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Mount Sinai Hospital· New York, NY

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