NCT07656818 Non-Thermal Plasma to Reduce Recurrence in Chronic Subdural Hematoma
| NCT ID | NCT07656818 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Benjamín Gonzalo Rodríguez Méndez |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-03-02 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomized controlled trial is to evaluate whether the adjuvant application of non-thermal plasma (NTP) during standard surgical drainage of chronic subdural hematoma (cSDH) can reduce the recurrence rate at 6 months. The main questions it aims to answer are: * Does NTP application significantly lower the radiological and clinical recurrence rate of cSDH compared to surgery alone? * Is NTP safe when applied to the subdural space and surgical wound bed? * Does NTP improve functional outcomes and time to hematoma resolution? Participants will be randomly assigned to one of two groups: * Experimental group (n = 20): Standard burr hole drainage or craniotomy plus intraoperative NTP application over the exposed dura mater, the residual membrane, soft tissue layers, and the skin incision. * Control group (n = 20): Standard surgical drainage alone (no NTP). Follow-up includes clinical assessments and computed tomography (CT) scans at 1 week, 3 months, and 6 months post-surgery. The primary outcome is recurrence (symptomatic reaccumulation requiring re-intervention or ≥50% volume increase on CT).
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07656818 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07656818 currently recruiting?
Yes, NCT07656818 is actively recruiting participants. Contact the research team at regulo.lopez@inin.gob.mx for enrollment information.
Where is the NCT07656818 trial being conducted?
This trial is being conducted at Ocoyoacac, Mexico.
Who is sponsoring the NCT07656818 clinical trial?
NCT07656818 is sponsored by Benjamín Gonzalo Rodríguez Méndez. The trial plans to enroll 40 participants.