NeoCast for Subdural Hematoma

(RADIANT Trial)

This trial tests a new treatment called the NeoCast Embolic System, a medical device, to determine its safety and effectiveness for people with subacute or chronic subdural hematoma (a type of brain bleed), in conjunction with surgery. Researchers compare it to an already approved treatment to identify the best option for patients. Individuals who have experienced symptoms like headaches, speech difficulties, or seizures due to a subdural hematoma in the last 30 days might be suitable for this study. Participants must plan to undergo a specific procedure called middle meningeal artery embolization soon after their surgery. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance treatment options for subdural hematoma.

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulants (blood thinners), you must be able to stop them for at least 7 days after surgery.

Research has shown that the NeoCast Embolic System, used to treat subdural hematomas, is generally safe for patients. In previous studies, over 80% of patients who received NeoCast treatment recovered well without needing additional surgery. Additionally, no serious side effects, such as major strokes or death related to brain issues, were reported within 30 days after the procedure. This suggests that the treatment is well-tolerated. Although some risk accompanies any medical procedure, the evidence so far indicates that NeoCast is a safe option for many people.¹²³⁴⁵

Researchers are excited about the NeoCast Embolic System for treating subdural hematomas because it offers a novel approach compared to the current standard of care. Traditional treatments often involve surgical intervention alone, but NeoCast adds an embolic system that works alongside surgery to target the middle meningeal artery (MMA). This adjunctive method could potentially enhance surgical outcomes by reducing blood flow to the hematoma, thereby minimizing the risk of recurrence and promoting faster recovery. Additionally, the NeoCast system is designed to be more precise, which may lead to fewer complications and a more targeted treatment approach.

Research has shown that the NeoCast Embolic System could be a promising treatment for subdural hematomas, a type of brain bleed. In one study, 87% of patients experienced successful treatment without needing additional surgery. Another study found that all targeted blood vessels were successfully blocked without affecting other areas. The NeoCast material is designed to penetrate deeply into blood vessels and does not adhere to other tissues, ensuring it remains where needed. In this trial, participants will be randomized to receive either the NeoCast Embolic System or an FDA-approved commercial liquid embolic as an active comparator. These findings suggest that NeoCast could effectively help manage subdural hematomas.¹²⁶⁷⁸