Trials / Not Yet Recruiting
Not Yet RecruitingNCT07214623
Prospective Multi-center Single Arm Study for Subjects With Chronic Subdural Hematoma Treated With i-ED COILs, Either Alone or in Combination With Burr-holes or Mini-craniotomy
i-ED COIL Use for Reduction of Chronic Subdural Hematoma Post Market Study
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Kaneka Medical America LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
All participants will be asked to have a minimally invasive procedure for the treatment of chronic subdural hematoma, a blood clot on the brain. Depending on the specific condition patients may also have a surgical procedure, a mini-craniotomy or burr holes where the skull is pierced and the blood clot is drained.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Neuro endovascular embolic coil | i-ED COIL, Kaneka Corporation |
Timeline
- Start date
- 2025-11-30
- Primary completion
- 2026-11-30
- Completion
- 2027-05-31
- First posted
- 2025-10-09
- Last updated
- 2025-10-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07214623. Inclusion in this directory is not an endorsement.