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NCT04270955 · ClinicalTrials.gov registry record · NA
Dartmouth Middle Meningeal Embolization Trial (DaMMET)
A NA study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT04270955 is a NA study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT04270955, a NA study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Chronic subdural hematomas (cSDH) are one form of bleeding in the head. They are one of the most common diseases encountered by neurosurgeons across the country. The cSDH can push on the brain and produce symptoms that include seizures, weakness, loss of sensation, and confusion. Many of these cSDH produce repetitive bleeding. Treatment has largely consisted of surgical drainage of hematoma (also known as a blood clot) through either a small hole in the skull or open surgery. However, it is common for the cSDH to reappear despite these procedures. A recent study has shown a treatment failure rate of 27% and a need for additional surgery at 19%. A new approach to treatment of cSDH blocks the blood supply to the tissue that produces the repeated bleeding. Catheters are used to gain access to the middle meningeal artery (MMA), an artery that supplies the coverings of the brain. The artery is blocked using small particles or glue in a process called embolization. A recent pilot study of 72 patients who underwent MMA embolization showed a much lower rate of repeated bleeding. Based on these results, it is thought that this procedure holds promise in reducing the number of cSDH that require one or more operations. The goal of this study is to systematically examine if blocking the blood supply to the tissue responsible for repeated bleeding helps the cSDH resolve and improves patient outcomes.
Interventions
- PROCEDURE Embolization of the Middle Meningeal Artery
- PROCEDURE Standard of care including possible surgical evacuation of subdural hematoma
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-03-11 |
| Est. Completion | 2024-01-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04270955
The ClinicalTrials.gov registry entry for NCT04270955 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Embolization of the Middle Meningeal Artery is the first listed.
NCT04270955 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04270955 about?
NCT04270955 is a clinical study titled "Dartmouth Middle Meningeal Embolization Trial (DaMMET)". Chronic subdural hematomas (cSDH) are one form of bleeding in the head. They are one of the most common diseases encountered by neurosurgeons across the country. The cSDH can push on the brain and produce symptoms that include seizures, weakness, loss of sensation, and confusion. Many of these cSDH ...
What is the current status of trial NCT04270955?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2020-03-11. Estimated completion is 2024-01-11.
What interventions are being tested in trial NCT04270955?
The interventions under investigation include: Embolization of the Middle Meningeal Artery (PROCEDURE), Standard of care including possible surgical evacuation of subdural hematoma (PROCEDURE).
Who is sponsoring clinical trial NCT04270955?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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