The CHALLENGER Registry
Recruiting
Observational Study
Chronic Subdural Hematoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 98
- Sex
- Any
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Other
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About This Trial
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 …
Trial Locations
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Eligibility 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…
Contacts