An interventional study of CT-Guided Intra-Operative Middle Meningeal Artery Interruption in Chronic Subdural Hematomas, sponsored by University College, London. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by University College, London · Not applicable, Interventional, and Treatment
Chronic subdural haematoma (cSDH) is a common condition in older adults, usually treated by burr-hole surgery to drain the collection. Even with good surgery, around 1 in 10 patients develop a recurrence and need a second operation. Research shows that the outer lining of the haematoma is fed by small branches of the middle meningeal artery (MMA), and interrupting these branches may lower the risk of recurrence.
This study looks at whether surgeons can safely and reliably coagulate these small MMA branches at the same time as standard burr-hole drainage, using the routine pre-operative CT scan and surgical navigation already used in everyday practice. Adults (aged 18 years and over) scheduled for burr-hole drainage of a chronic or subacute subdural haematoma will be invited to take part. The procedure, recovery, drain management, and 90-day follow-up will otherwise follow standard NHS care.
No additional imaging is required for the study, and participants are not exposed to any extra radiation. The main purpose is feasibility and safety, not to prove effectiveness. Findings will inform the design of a future multicentre study.
Recurrence after burr-hole drainage of chronic subdural haematoma is driven largely by a vascularised outer membrane supplied by distal convexity branches of the middle meningeal artery. Endovascular MMA embolisation can reduce recurrence but requires a separate interventional radiology procedure and is not uniformly available across NHS centres.
BURR-MMA evaluates an alternative, in-workflow approach: limited bipolar coagulation of distal convexity MMA branches performed through the planned burr-hole during standard evacuation. Pre-operative non-contrast CT is used to map the MMA bony groove, and routine CE-marked neuronavigation is used to standardise targeting. No additional burr-holes, implants, drugs, or research-specific imaging are introduced.
This is an IDEAL Stage 2a, single-centre, single-arm feasibility study enrolling 20-30 adults undergoing burr-hole surgery for cSDH. The primary focus is technical deliverability, safety, procedural fidelity, and characterisation of iterative technique refinement. Exploratory clinical outcomes are collected to Day 90 to inform endpoint selection and sample-size calculations for a future IDEAL Stage 2b multicentre cohort study. All CT imaging is performed as part of routine clinical care; participants receive no additional ionising radiation because of study participation. The study is not powered to assess clinical effectiveness.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 30 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Consented participants who meet eligibility criteria will be enrolled sequentially until the target sample size of 20-30 participants is reached. No randomisation is used in this feasibility phase.
Exclusion Criteria:
If CT is non-diagnostic or cannot be performed, participants will continue with standard burr-hole evacuation without the MMA adjunct; this does not constitute a protocol deviation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this single-arm feasibility study will undergo standard burr-hole evacuation of chronic subdural haematoma with subdural drain placement, in accordance with routine clinical practice. In addition, a CT- and neuronavigation-guided intra-operative adjunct will be attempted to identify and interrupt distal convexity branches of the middle meningeal artery (MMA) supplying the haematoma membrane, where this is considered safe and technically feasible by the operating surgeon. The adjunct involves minor adjustment of burr-hole position within the haematoma footprint and limited bipolar coagulation of target MMA branches. If safe identification or access is not possible, the adjunct will be omitted and standard surgery completed. All imaging and peri-operative care are part of standard clinical practice. The study is designed to assess feasibility, safety, procedural fidelity and workflow integration rather than clinical effectiveness.
Procedure: CT-Guided Intra-Operative Middle Meningeal Artery Interruption
This intervention is a surgical adjunct performed during standard burr-hole evacuation of chronic subdural haematoma. Using pre-operative non-contrast CT and intra-operative neuronavigation, the surgeon identifies distal convexity branches of the middle meningeal artery (MMA) supplying the haematoma membrane. Where safely accessible, limited bipolar coagulation is applied to interrupt these branches through the planned burr-hole. Burr-hole position may be slightly adjusted within the haematoma footprint to facilitate safe targeting. If branches cannot be confidently identified or safely accessed, the adjunct is omitted and standard surgery is completed. No additional imaging or devices are introduced beyond routine clinical care.
Also known as: MMA coagulation during burr-hole surgery, Intra-operative MMA interruption
Technical Success of the MMA Adjunct
Proportion of procedures in which one or more intended distal convexity MMA branches are successfully identified and coagulated by the operating surgeon, confirmed intra-operatively and by post-operative non-contrast CT showing burr-hole placement over the expected MMA bony groove. Reported as a percentage (0-100%); higher values indicate greater technical deliverability.
Time frame: Intra-operative (during index procedure) and on first post-operative non-contrast CT, up to 72 hours post-operatively.
Incidence of Technique-Related Adverse Events
Number of participants experiencing at least one adverse event judged by the investigator to be related to the MMA adjunct (e.g., thermal injury, additional bleeding, equipment-related events). Reported as a count and percentage of enrolled participants.
Time frame: Intra-operative through 90 days post-operatively.
Incidence of Serious Adverse Events
Number of participants experiencing at least one serious adverse event (as defined by ICH-GCP), regardless of causality. Reported as a count and percentage of enrolled participants
Time frame: From index procedure through 90 days post-operatively.
Completeness of Day-90 Outcome Data Capture
Proportion of enrolled participants with complete primary outcome data available at the Day-90 follow-up, against a pre-specified feasibility target of ≥95%. Reported as a percentage.
Time frame: At 90 days post-operatively.
Incidence of cSDH Recurrence Requiring Re-Intervention
Proportion of participants with radiological recurrence (increase in subdural collection size) accompanied by clinical deterioration requiring re-drainage, repeat burr-hole surgery, or rescue MMA embolisation, as determined by the treating neurosurgeon. Reported as a percentage.
Time frame: Up to 90 days post-operatively
Length of Hospital Stay
Total duration of the index hospital admission, from date of surgery to date of discharge, measured in days.
Time frame: During index admission (up to discharge, assessed up to 90 days post-operatively).
Incidence of Peri-Operative Complications
Number of participants experiencing one or more peri-operative surgical or medical complications (e.g., wound infection, seizure, pneumonia, venous thromboembolism, acute subdural haematoma). Reported as a count and percentage.
Time frame: Intra-operative through 30 and 90 days post-operatively.
Incidence of Unplanned Hospital Readmission
Proportion of participants with at least one unplanned readmission to any hospital following discharge from the index admission. Reported as a percentage.
Time frame: From discharge through 90 days post-operatively.
Functional Outcome Measured by the Modified Rankin Scale (mRS)
Functional status measured using the Modified Rankin Scale (mRS), a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death). Lower scores indicate better functional outcome.
Time frame: At 90 days post-operatively.
Health-Related Quality of Life Measured by the EQ-5D-5L Utility Index
Health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument, reported as a single utility index value derived using the UK value set. Scores range from less than 0 (worse than dead) to 1 (full health); higher scores indicate better health-related quality of life.
Time frame: At 90 days post-operatively.
Added Operative Time Attributable to the MMA Adjunct
Additional intra-operative time required to perform the MMA coagulation adjunct, measured from adjunct start to adjunct stop, in minutes.
Time frame: Intra-operative (during index procedure).
Procedural Fidelity to the Pre-Specified Surgical SOP
Proportion of procedures in which all pre-specified SOP steps (navigation registration within tolerance, targeting of distal convexity branches only, adherence to avoidance zones, documentation completeness) are fully executed without protocol-defined deviation. Reported as a percentage.
Time frame: Intra-operative (during index procedure).
Learning Effect on Added Operative Time Across Sequential Cases
Change in added operative time for the MMA adjunct across sequential cases, analysed descriptively using cumulative sum (CUSUM) methodology to identify the case number at which added operative time stabilises. Reported in minutes per case.
Time frame: Through study completion (up to 12 months).
Concordance Between Pre-Operative CT MMA Groove and Intra-Operative Findings
Proportion of cases in which the distal convexity MMA branch location identified on pre-operative thin-slice non-contrast CT (via the MMA bony groove) is confirmed by intra-operative visualisation through the planned burr-hole. Reported as a percentage.
Time frame: Intra-operative (during index procedure), compared against pre-operative CT performed within 7 days prior to surgery.
Feasibility of Prospective Healthcare Resource-Use Data Collection
Proportion of enrolled participants with complete prospective records of pre-defined healthcare resource-use items (length of stay, critical care days, re-operations, readmissions, rescue MMA embolisation, discharge destination) captured via the study eCRF. Reported as a percentage against a pre-specified target of ≥90%.
Time frame: Through 90 days post-operatively.
Plan to share: Yes — De-identified individual participant data (IPD) underlying the results reported in publications will be made available. This will include demographic data, clinical characteristics, imaging-derived variables, intra-operative procedural data, and outcome measures (including feasibility metrics, adverse events, and 90-day outcomes). All data will be pseudonymised, with no directly identifiable information shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available beginning 6-12 months following publication of the primary study results and will remain available for up to 5 years thereafter, subject to data governance and sponsor approval.
Access criteria: Access will be provided to researchers with a methodologically sound proposal that is consistent with the aims of the original study. Requests will be reviewed by the study team and Sponsor. Data will be shared under a formal data sharing agreement and in accordance with applicable data protection regulations. Access will be limited to de-identified data and may be provided via secure institutional platforms.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.
Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 11 months is below that.
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