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NCT07197840 · ClinicalTrials.gov registry record
The CHALLENGER Registry
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Not yet
- Registry status
- 100
- Enrollment target
NCT07197840: Clinical Trial study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT07197840 is a clinical trial that has not yet begun recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07197840 has not yet begun recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- NOT YET RECRUITING
- Registry status
- 100 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The proportion of patients centrally deemed to need rescue surgery or die within 180 days of MMA coil embolization
Interventions
- DEVICE Numen SILK coil embolization system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-03-01 |
| Est. Completion | 2028-03-01 |
What is known before NCT07197840 opens enrollment
NCT07197840 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Numen SILK coil embolization system is the first listed.
NCT07197840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07197840 about?
NCT07197840 is a clinical study titled "The CHALLENGER Registry". 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 me...
What is the current status of trial NCT07197840?
This trial is currently not yet recruiting. The enrollment target is 100 participants. The study started on 2026-03-01. Estimated completion is 2028-03-01.
What interventions are being tested in trial NCT07197840?
The interventions under investigation include: Numen SILK coil embolization system (DEVICE).
Who is sponsoring clinical trial NCT07197840?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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