First in Human Study of the Safety and Feasibility of Middle Meningeal Artery (MMA) Embolisation with the Arsenal Medical NeoCast Embolic System for the Treatment of Chronic Subdural Hematoma (cSDH)

Arsenal Medical Australia Pty Ltd.0 sites10 target enrollmentMay 22, 2024

Overview

No summary available.

Registry

who.int

Start Date

May 22, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Arsenal Medical Australia Pty Ltd.

•Subject whose age is greater than or equal to 18 years and less than or equal to 90 years;
•Subject whose pre\-morbid mRS score is less than or equal to 2
•Confirmed diagnosis of a symptomatic chronic subdural hematoma that measures greater than or equal to 10 mm in greatest thickness
•Subject is planned for Middle Meningeal Artery embolisation for cSDH, either adjunctive to surgery or as part of medical management
•Subject understands the nature of the procedure, consents to participation in the study and provides a signed informed consent form;
•Subject (woman of child\-bearing potential) with a current negative pregnancy test who has agreed to an appropriate method of contraception throughout the trial;
•Subject is willing to return to the investigational site for follow\-up visits.
•Baseline Inclusion Criteria:
•A negative pregnancy test is required at baseline for a woman of child\-bearing potential

•Screening Exclusion Criteria:
•Diagnosed with acute SDH
•Subject with prior embolisation of either MMA
•Subject with urgent or emergent (within 1 hour of assessment) subdural hematoma evacuation needed
•Subject who presents with a meningioma greater than or equal to 1 cm or less than 1 cm with mass effect
•Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
•Structural pathology causing the cSDH (e.g., dural AV fistula, AVM, tumor, arachnoid cyst, ventriculoperitoneal shunt)
•Presumed microbial superinfection
•Subject who is breastfeeding
•Subject with life expectancy of less than 1 year