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NCT03307395 · ClinicalTrials.gov registry record · NA

Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma

A NA study of Chronic Subdural Hematoma, sponsored by Weill Medical College of Cornell University.

Completed
Registry status
NA
Development phase
6
Enrollment target
1
Study location

NCT03307395: Completed NA study of Chronic Subdural Hematoma, sponsored by Weill Medical College of Cornell University.

NCT03307395 is a NA study of Chronic Subdural Hematoma that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 6 participants, below the 1,440-participant average among 4 other Chronic Subdural Hematoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03307395, a NA study of Chronic Subdural Hematoma, has completed, sponsored by Weill Medical College of Cornell University.

COMPLETED
Registry status
NA
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has been attempted with the goal of eliminating the arterial supply to the vascularized membrane. The investigators have recently presented the first known case series of MMA embolization as upfront treatment for cSDH in lieu of surgical evacuation (publication pending). Five patients underwent successful embolization of the MMA with subsequent reduction in size or complete resolution of cSDH with no peri-procedural complications. The purpose of this study will be to evaluate the safety and efficacy of MMA embolization compared to traditional surgical management for symptomatic, chronic, and medically refractory SDH. MMA embolization is an established procedure used routinely for treatment of tumors or vascular malformations; this study investigates the use of an established procedure for a new disease. The investigators hypothesize that MMA embolization will afford a particularly fragile patient population an alternative to invasive and morbid neurosurgical intervention.

Primary Outcome

A neurological exam will be performed to assess any neurological changes post-procedure.

Conditions Studied

Interventions

  • PROCEDURE Middel Meningeal Artery Embolization

Study Locations (1)

New York

  • Weill Cornell Medical College - New York

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2017-10-31
Est. Completion 2018-07-30
Phase NA

What the finished NCT03307395 record still lists

NCT03307395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 1,440-participant average among 4 other Chronic Subdural Hematoma trials with a reported enrollment target (100% lower).

The record links to 1 condition, with Chronic Subdural Hematoma appearing as the primary indexed condition, and to 1 intervention - of which Middel Meningeal Artery Embolization is the first listed.

NCT03307395 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03307395 about?

NCT03307395 is a clinical study titled "Middle Meningeal Artery Embolization for Treatment of Chronic Subdural Hematoma". Middle meningeal artery (MMA) embolization via a minimally invasive endovascular approach has been attempted with the goal of eliminating the arterial supply to the vascularized membrane. The investigators have recently presented the first known case series of MMA embolization as upfront treatment f...

What is the current status of trial NCT03307395?

This trial is currently completed. It is a NA study. The enrollment target is 6 participants. The study started on 2017-10-31. Estimated completion is 2018-07-30.

What conditions does trial NCT03307395 study?

This clinical trial studies the following conditions: Chronic Subdural Hematoma.

What interventions are being tested in trial NCT03307395?

The interventions under investigation include: Middel Meningeal Artery Embolization (PROCEDURE).

Who is sponsoring clinical trial NCT03307395?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03307395 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03307395, the US trial registry maintained by the National Library of Medicine. NCT03307395 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.