Status:
RECRUITING
Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization
Lead Sponsor:
University Hospital, Brest
Conditions:
Chronic Subdural Hematoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem,...
Detailed Description
* Indication of surgical or conservative management will be decided by the neurosurgeon. * Experimental arm: CSH requiring hematoma removal will be surgically managed with a surgical technique applie...
Eligibility Criteria
Inclusion
- Patient with a more than 10 mm CSH confirmed by NCCT
- CSH localized to convexity
- Patient aged 18 years or more at the time of the enrollment
- Patient beneficiary from health insurance
Exclusion
- Any contraindication as required per angiogram procedure (severe renal failure, allergy…)
- Pre-existing severe disability resulting in baseline mRS score \> 3
- Life expectancy of less than 6 months due to another cause than CSH
- Patient under legal protection or deprived of liberty by a judicial or administrative decision
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
March 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 28 2026
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT05374681
Start Date
March 28 2023
End Date
September 28 2026
Last Update
February 6 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Amiens-Picardie
Amiens, France, France, 80054
2
CHU Brest
Brest, France, France, 29609
3
CHU Caen
Caen, France, France, 14000
4
CHU Nantes
Nantes, France, France, 44000