An interventional study of Minimally Invasive Cortical Access System (MICAS) in Chronic Subdural Hematoma, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Device feasibility
Among 21 studies in Hematoma, Subdural, Chronic with a site in United States — 9 open to participants now, 9 under way, none of them phase 3. Hematoma, Subdural, Chronic · United States.
Among the 21 studies in Hematoma, Subdural, Chronic with a site in United States, this one is the 11th largest by enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2020, is one of 10 with no phase, and was the 9th registered.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
Browse Hematoma, Subdural, Chronic studies →9 of the 21 studies in Hematoma, Subdural, Chronic with a site in United States are open now. Recruiting first, the newest first:
Arsenal Medical, Inc. · Sites in United States
Ages 18–90
Icahn School of Medicine at Mount Sinai · Sites in United States
Ages 18+
Ohio State University · Sites in United States
Ages 18+
Lahey Clinic · Sites in United States
Ages 18+
The University of Texas Medical Branch, Galveston · Sites in United States
Ages 40–90
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 35 Hematoma, Subdural, Chronic studies recruiting now, 26 (74%) set no upper age limit and 1 (3%) stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 55 Years and older · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 3 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Median enrollment 35 across the 14 interventional studies, 100 across the 7 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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4 of 21 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,270 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 1 study filed under Hematoma, Subdural, Chronic — fewer than ten, so there is no comparison to draw.
4 of the studies in Hematoma, Subdural, Chronic with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07214623Kaneka Medical America LLCProspective 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 | 2026-11-30 |
| NCT06181994Montefiore Medical CenterMiddle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH) | 2026-12 |
| NCT07715656Lahey ClinicAssessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas | 2027-04-30 |
| NCT07757113Sanford HealthComparative Study of Embolic Agents in Patients With Subdural Hemorrhage Undergoing Middle Meningeal Artery (MMA) Embolization | 2027-09 |
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Among the 21 studies in Hematoma, Subdural, Chronic with a site in United States, from their registry updates:
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The purpose of this study is to evaluate a less-invasive alternative to the currently available method of removing aging blood in the subdural space.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During clinically indicated surgery for subdural hematoma, the patient will undergo a single burr hole evacuation with the MICAS device with endoscopic assistance.
Device: Minimally Invasive Cortical Access System (MICAS)
Temporary surgical tool that provides access to the sub-dural space through the cranium.
Incidence of all serious adverse events
Number of adverse events including unanticipated adverse device effects
Time frame: 3 years
Plan to share: No
Ran from Oct 2020 to primary completion in Oct 2023, 36 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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