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Cold plasma zaps brain bleed comeback risk in small trial

NCT ID NCT07656818

Disease control Sponsor: Benjamín Gonzalo Rodríguez Méndez Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests whether applying a cold, non-thermal plasma (a kind of energized gas) to the surgical site during standard drainage of a chronic subdural hematoma (a slow brain bleed) can lower the chance it comes back. Forty adults needing surgery will be randomly assigned to get standard surgery alone or surgery plus the plasma treatment. They will be followed for 6 months with scans and checkups to see if the bleed returns.

What this could mean

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

Active substance
Non-thermal plasma (helium gas, 20 Watts, 0.5 LPM)
What this could lead to
If it works, this could offer a simple, low-cost way to lower the chance of a chronic subdural hematoma coming back after surgery.
What could go wrong
This is a very small early trial (40 people) testing a new use for a device. The effect may be small or absent, and the procedure carries standard surgical risks like infection or bleeding.

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 40 people

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

Started

Mar 2026

Expected to finish

Apr 2027

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: * Adults ≥ 18 years of age * Diagnosis of symptomatic chronic subdural hematoma (cSDH) requiring surgical drainage (burr hole drainage or craniotomy) * Ability to provide written informed consent (or consent from legal representative if patient is incapacitated) Exclusion Criteria: * Pure acute or subacute subdural hematoma * Uncontrolled coagulopathy or bleeding disorder * History of intracranial aneurysm or prior cerebrovascular event with residual deficit * Presence of active intracranial metallic implants or electronic devices (e.g., programmable shunt, cardiac pacemaker, deep brain stimulator) in the head region * Pregnancy or lactation * Participation in another interventional clinical trial within 30 days prior to screening

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Conditions

The condition(s) this trial relates to.

Hematoma, Subdural Hematoma, Subdural, Chronic Postoperative Complications Recurrence

As listed by the trial registrant

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

Chronic subdural hematoma Postoperative complications Recurrence 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

  • Plasma Physics Laboratory, National Institute of Nuclear Research

    RECRUITING

    Ocoyoacac, State of Mexico, 52750, Mexico

More trials for these conditions

Other studies related to the condition(s) this trial covers.