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3D-Printed brain surgery guide may stop dangerous blood clots from returning

NCT ID NCT07720687

Disease control Sponsor: The Second Hospital of Anhui Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

Chronic subdural hematoma is a blood collection on the brain's surface common in older adults. Standard drainage surgery works, but the clot can come back. This trial tests whether using a custom 3D-printed template to guide the surgery, plus sealing a nearby artery during the procedure, can lower the risk of recurrence. About 440 adults needing surgery will be randomly assigned to the new approach or standard care, and followed for three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a patient-specific 3D-printed surgical template combined with intraoperative coagulation of the middle meningeal artery
What this could lead to
If successful, this approach could lower the chance that a chronic subdural hematoma comes back after surgery, reducing the need for repeat procedures.
What could go wrong
This is a relatively early-stage trial, and the added procedure may not reduce recurrence or could carry extra risks like bleeding or damage to nearby structures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 440 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Patients diagnosed with chronic subdural hematoma based on clinical symptoms and cranial CT or MRI. * Patients scheduled to undergo burr-hole drainage surgery. * Age 18 years or older. * Written informed consent obtained from the patient or legal representative. Exclusion Criteria * Acute subdural hematoma or other intracranial lesions requiring different surgical management. * Previous surgery for the same episode of chronic subdural hematoma. * Severe coagulation disorder or other contraindications to surgery. * Severe systemic disease making the patient unsuitable for participation. * Refusal or inability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural, Chronic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic subdural hematoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

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