None listed
Conditions
Brief summary
The EMBO-02 study is a first-in-human study for treatment of chronic subdural hematomas, which is a collection of blood and blood breakdown products, like a blood clot. A hematoma that is subdural is located between the surface of the brain and its outermost covering (the dura). A subdural hematoma develops when tiny blood vessels that run between the dura and surface of the brain tear and begin to leak. Participants in this study may benefit from “embolisation” to stop the blood vessels from leaking. This research study is testing a new investigational device that is an embolic agent called the NeoCast Embolic System (“NeoCast”).
Interventions
Participants diagnosed with chronic subdural hematoma (cSDH) will undergo embolisation with a novel embolic agent, NeoCast (formerly Distal Penetrating Embolic, or DPE) in a procedure performed by a board-certified neurointerventional radiologist. A subdural hematoma develops when tiny blood vessels that run between the surface of the brain and its outermost covering (the dura) tear and begin to leak. Embolisation is a procedure that blocks off the blood supply in the leaky vessels by injectin
Participants diagnosed with chronic subdural hematoma (cSDH) will undergo embolisation with a novel embolic agent, NeoCast (formerly Distal Penetrating Embolic, or DPE) in a procedure performed by a board-certified neurointerventional radiologist. A subdural hematoma develops when tiny blood vessels that run between the surface of the brain and its outermost covering (the dura) tear and begin to leak. Embolisation is a procedure that blocks off the blood supply in the leaky vessels by injecting an embolic agent into the blood vessels to form a plug within the vessels to stop blood flow. The embolisation procedure will be done in an operating room and is expected to take about 2 hours. The embolisation procedure may be done under conscious sedation or general anesthesia. Before the procedure starts, baseline computed tomography (CT) imaging is done to take pictures of the blood vessels in the brain that supply the hematoma. A catheter (a thin, flexible tube) is inserted into a small incision in the inner thigh or wrist and advanced through the blood vessels into the brain. During this time contrast dye will be injected into the catheter and x-ray images (digital subtractive angiography) are taken. Once the catheter is placed at the vessel which needs to be embolised, NeoCast is injected until the material fills the blood vessel and stops the blood leaking to the hematoma. X-ray images (digital subtractive angiography) will be taken of the embolised blood vessel(s). At the end of the procedure CT imaging is repeated to record the placement of the embolic material. A Sponsor representative who is a technical expert on NeoCast will attend the embolisation procedure and make sure the protocol is being followed and all the information about the procedure is recorded according to the protocol. The CT and X-ray images from the procedure will be reviewed by an Imaging Core Lab to make sure the embolisation procedure was successful in placing NeoCast where it was needed to stop the blood leakage, and that no NeoCast was placed where it was not needed. The NeoCast procedure may not be repeated if post-embolisation CT imaging indicates failure of the initial procedure. Separately, study participants may have their hematoma surgically drained either before or after embolisation. This separate surgical procedure would be done by a neurosurgeon according to hospital standard of care. Participants will be followed through 6 months post-embolisation, with CT imaging repeated at a 6-week follow-up visit and a 3-month follow-up visit, and finally at a 6-month follow-up visit if the cSDH has not resolved. The imaging will be used to measure changes from baseline in hematoma thickness, hematoma volume, and degree of midline shift.
Sponsors
Arsenal Medical Australia Pty Ltd.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
• 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 • The Participant’s embolisation procedure is planned to be performed under conscious sedation; however, if necessary, the Participant must be able to tolerate general anesthesia • 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
Exclusion criteria
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 • Patients with acute renal impairment that the investigator assesses could be at risk for contrast induced nephropathy • Subject with a life-threatening allergy to radiographic contrast (unless treatment for allergy is tolerated or can be managed medically) • Participant is allergic to any of the materials used in the NeoCast device • Planned embolisation procedure that would require use of a microcatheter with lumen diameter < 0.016 in • Subject who is currently participating or planning to participate within 6 months in another non-observational clinical research study Baseline Exclusion Criteria: • Digital subtractive angiography (DSA) demonstrates potentially dangerous anatomic variations leading to increased procedural risk or unsafe access for MMA embolisation (i.e., MMA originating from ophthalmic artery)
Outcome results
None listed