CSF LeakPSEUDONCT07614399
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
A study testing Lumbar Drainage, Pseudomeningocele Puncture and Puncture with Fibrin Glue Application in people with CSF Leak and CSF Pressure Increased, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Dear Sir or Madam, You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative management and interventional treatment (surgical or drainage procedures). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- CSF Leak, CSF Pressure Increased, CSF Circulation Disorder
- What is being tested?
- Lumbar Drainage, Pseudomeningocele Puncture and Puncture with Fibrin Glue Application
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2025to 1 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pseudomeningocele after elective intracranial surgery
- Willing and able to give informed consent
- No prior cranial or spinal surgical intervention
- Pseudomeningocele Palpation Scale (PPS) II-IV, no severe pain of the PMC (VAS 7-10) - Tension MK
Who cannot join
- PMC following emergency or trauma surgery
- Known or suspected infection at the PMC site at recruitment
- Severe comorbidities preventing participation (e.g. terminal illness, organ failure)
- Conditions requiring urgent unrelated surgical intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Military University Hospital Prague
Prague, Prague, 16000
Norbert Svoboda, MD, PhD, FEBNS, ++420973202932, norbert.svoboda@uvn.cz
Martin Majovsky, MD, Ass. Prof., PhD, FEBNS, +420973202963, martin.majovsky@uvn.cz
About this study
Official title: Conservative Versus Interventional Management of Postsurgical CSF Pseudomeningocele: A Randomized Controlled Trial
Dear Sir or Madam,
You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative management and interventional treatment (surgical or drainage procedures). CSF pseudomeningocele is a complication that may occur after brain surgery and is characterized by an accumulation of cerebrospinal fluid beneath the skin. At present, there is no clear consensus regarding the optimal treatment approach.
Read more
How the study will be conducted
After enrollment in the study, you will be randomly assigned (by chance) to one of two groups:
Conservative management: no surgical intervention, regular follow-up, and wound care.
Interventional treatment: simple aspiration/puncture, insertion of a lumbar drain, or reoperation.
During the study, you will be followed for a period of 1 year. Follow-up examinations will include clinical assessment and brain imaging (CT or MRI) at 4 months and 12 months after enrollment.
Risks associated with the interventional group Simple cyst aspiration/puncture: infection, bleeding into the pseudomeningocele.
Lumbar drainage: infection, meningitis, bleeding at the insertion site, cerebrospinal fluid leakage, nerve root irritation, headaches.
Reoperation: bleeding, infection, complications related to general anesthesia. Expected duration of participation in the study
12 months
Expected total number of participants enrolled in the study
20 participants
Benefit of the study
The aim of the study is to compare the effect of surgical intervention with conservative management.
Compensation for participation
Participation in this study is not associated with any financial compensation.
- Conditions
- CSF Leak, CSF Pressure Increased, CSF Circulation Disorder, Puncture
- Being tested
- Lumbar Drainage, Pseudomeningocele Puncture, Puncture with Fibrin Glue Application, Revision
- Keywords
- Cerebrospinal Fluid Leak, Postoperative Complications, Neurosurgery
- Medical subject headings
- Cerebrospinal Fluid Otorrhea, Intracranial Hypertension, Cerebrospinal Fluid Leak, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar DrainageProcedure or surgery
Insertion of Lumbar drain
Pseudomeningocele PunctureProcedure or surgery
aspiration of the CSF fluid with injection
Puncture with Fibrin Glue ApplicationProcedure or surgery
after aspiration of the CSF a fibrin glue is injected into the pseudomeningocele
RevisionProcedure or surgery
Revision surgery in order to prevent future pseudomeninogocele formation
| Study group | Role | What they receive |
|---|---|---|
| Conservative | No intervention | Patients managed without surgical procedures, except for skin sutures. |
| Interventional | Experimental | Patients undergoing local treatment - lumbar drainage insertion, simple wound puncture, fibrin glue or any combination. Receives: Procedure: Lumbar Drainage; Procedure: Pseudomeningocele Puncture; Procedure: Puncture with Fibrin Glue Application; Procedure: Revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF Leakage or Tension pseudomeningocoele
New-onset wound CSF leakage requiring revision surgery, or pseudomeningocele associated with severe headaches not responsive to analgesics.
Measured: 12 months
Secondary outcomes (4)
Infection
To compare the infection rate between the two treatment groups.
Measured: 12 months
Glasgow Outcome Scale Extended (GOSE)
To assess functional recovery using the Glasgow Outcome Scale-Extended (GOSE) at 1 year post-surgery.
Measured: 12 months
Absorption of the Pseudomeningocoele
Absorption of pseudomendingocoele at 4 months and 1 year post-surgery assessed by CT or MRI
Measured: 12 months
Pain
Persistence of headache after the surgery - Pain Scale 0-10 (VAS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Nov 2025
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSF LeakStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norbert Svoboda, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614399
- Sponsor's protocol ID
- 108/20-55/2025
- Acronym
- PSEUDO
- Status last verified
- May 2026
- First submitted
- 15 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Interventional Management of Postsurgical CSF Pseudomeningocele: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07614399
- Acronym / sponsor ID
- PSEUDO / 108/20-55/2025
- Conditions
- CSF Leak, CSF Pressure Increased, CSF Circulation Disorder, Puncture
- Keywords
- Cerebrospinal Fluid Leak, Postoperative Complications, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2030 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dear Sir or Madam,
You have been invited to participate in a clinical study whose aim is to compare the effectiveness of two different approaches to the treatment of cerebrospinal fluid (CSF) pseudomeningocele - conservative management and interventional treatment (surgical or drainage procedures). CSF pseudomeningocele is a complication that may occur after brain surgery and is characterized by an accumulation of cerebrospinal fluid beneath the skin. At present, there is no clear consensus regarding the optimal treatment approach.
How the study will be conducted
After enrollment in the study, you will be randomly assigned (by chance) to one of two groups:
Conservative management: no surgical intervention, regular follow-up, and wound care.
Interventional treatment: simple aspiration/puncture, insertion of a lumbar drain, or reoperation.
During the study, you will be followed for a period of 1 year. Follow-up examinations will include clinical assessment and brain imaging (CT or MRI) at 4 months and 12 months after enrollment.
Risks associated with the interventional group Simple cyst aspiration/puncture: infection, bleeding into the pseudomeningocele.
Lumbar drainage: infection, meningitis, bleeding at the insertion site, cerebrospinal fluid leakage, nerve root irritation, headaches.
Reoperation: bleeding, infection, complications related to general anesthesia. Expected duration of participation in the study
12 months
Expected total number of participants enrolled in the study
20 participants
Benefit of the study
The aim of the study is to compare the effect of surgical intervention with conservative management.
Compensation for participation
Participation in this study is not associated with any financial compensation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | No intervention | –Patients managed without surgical procedures, except for skin sutures. |
| Interventional | Experimental | Procedure: Lumbar Drainage, Procedure: Pseudomeningocele Puncture, Procedure: Puncture with Fibrin Glue Application, Procedure: RevisionPatients undergoing local treatment - lumbar drainage insertion, simple wound puncture, fibrin glue or any combination. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pseudomeningocele after elective intracranial surgery
- Willing and able to give informed consent
- No prior cranial or spinal surgical intervention
- Pseudomeningocele Palpation Scale (PPS) II-IV, no severe pain of the PMC (VAS 7-10) - Tension MK
Key exclusion criteria (4 listed)
- PMC following emergency or trauma surgery
- Known or suspected infection at the PMC site at recruitment
- Severe comorbidities preventing participation (e.g. terminal illness, organ failure)
- Conditions requiring urgent unrelated surgical intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar DrainageInsertion of Lumbar drain | Procedure or surgery | Interventional |
| Pseudomeningocele Punctureaspiration of the CSF fluid with injection | Procedure or surgery | Interventional |
| Puncture with Fibrin Glue Applicationafter aspiration of the CSF a fibrin glue is injected into the pseudomeningocele | Procedure or surgery | Interventional |
| RevisionRevision surgery in order to prevent future pseudomeninogocele formation | Procedure or surgery | Interventional |
Primary outcome
CSF Leakage or Tension pseudomeningocoele
Time frame: 12 months
New-onset wound CSF leakage requiring revision surgery, or pseudomeningocele associated with severe headaches not responsive to analgesics.
4 secondary outcomes
Infection
Time frame: 12 months
Glasgow Outcome Scale Extended (GOSE)
Time frame: 12 months
Absorption of the Pseudomeningocoele
Time frame: 12 months
Pain
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar Drainage, Pseudomeningocele Puncture and Puncture with Fibrin Glue Application in people with CSF Leak and CSF Pressure Increased, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norbert Svoboda, MD, PhD, FEBNS (++420973202932, norbert.svoboda@uvn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF Leakage or Tension pseudomeningocoele (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.