Assessing Outcomes of Coil Embolization for Unilateral vs Bilateral Chronic Subdural Hematomas (NCT07715656)

🧪 Interventions in This Study

• embolization therapy Bilateral (DEVICE)
• embolization therapy Unilateral (DEVICE)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Candidates for this study must meet ALL of the following criteria:
2. Subject is 18 years of age or older.
3. Subject has a diagnosis of chronic subdural hematoma with mass effect Determined by brain imaging (CT or MRI) and correlated clinical symptoms.
4. Pre-randomization modified Rankin Score (mRS) ≤3 a. Surgical Cohort: Assessment should reflect the subject's condition just prior to undergoing surgery. Assessment may be performed post-surgery using pre-surgical data.
5. Subdural Hematoma Size Medical Management Cohort:
6. Midline shift \< 10mm and hematoma thickness \> 10 mm as measured on coronal imaging perpendicular to the skull.
7. No focal deficit related to the chronic subdural hematoma requiring surgical intervention Surgical Cohort:
8. No requirement
9. A CT performed prior to randomization demonstrating stability of the hematoma. Stability is defined as no worsening of midline shift or increase in the size of the cSDH from the screening image that results in new or worsening clinical symptoms.
10. Patient or designated Legal Authorized Representative, confirms the patient has the mental capacity, willingness and ability to comply with protocol and follow-up requirements
11. In the opinion of the treating physician, MMA embolization is technically feasible, including evaluation of preoperative CTA, if available, or presence of a foramen spinosum bilaterally.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Lahey Hospital & Medical Center — Burlington, Massachusetts

📞 Contact the Study Coordinator

Phone: (786) 580-0186

Email: sandy.l.alvarez@lahey.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: In which subjects will receive either unilateral or bilateral middle meningeal artery (MMA) embolization using coils for the treatment of unilateral chronic subdural hematomas (cSDH).

More studies in Chronic Subdural Hematoma

• Middle Meningeal Artery Embolization (MMAE) Outcomes for Chronic Subdural Hematoma (cSDH) — Coral Gables, Florida
• The CHALLENGER Registry — New York, New York
• Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence — Medellín, Antioquia
• Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma — Ocoyoacac, State of Mexico
• Microfabricated Microcatheter Advantages in Middle Meningeal Artery Embolization: an Early Experience at a Single Center — Columbus, Ohio

Explore by condition: All Chronic Subdural Hematoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.