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Compares treatment options for CerebroSpinal Fluid (CSF) Leak
Official title NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
ClinicalTrials.gov ID: NCT07216157
What this study is testing
- What it's testing
- Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synthetic agents (PEI/PEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction
- Informed written consent obtained prior to enrollment
- Hemodynamic and electrolyte stability before surgery
- Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques
You likely can't join if
- Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects)
- Tumors requiring complex sella reconstruction from the start
- Preoperative hydrocephalus
- Known allergy to fibrin-based or synthetic sealant components
- Active sinus infection or systemic inflammatory disease
- Prior radiotherapy to the sellar or parasellar region
See the full eligibility criteria
- Age ≥ 18 years
- Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction
- Informed written consent obtained prior to enrollment
- Hemodynamic and electrolyte stability before surgery
- Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques
- Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects)
- Tumors requiring complex sella reconstruction from the start
- Preoperative hydrocephalus
- Known allergy to fibrin-based or synthetic sealant components
- Active sinus infection or systemic inflammatory disease
- Prior radiotherapy to the sellar or parasellar region
- Uncontrolled diabetes mellitus (HbA1c \> 7.0%)
- Participation in another treatment trial that may influence wound healing or CSF assessment
- Radiologic signs of chronic intracranial hypertension or hypotension
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.