Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT07216157
Eligibility Criteria:
Inclusion 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
Exclusion Criteria:
* 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 interventional trial that may influence wound healing or CSF assessment
* Radiologic signs of chronic intracranial hypertension or hypotension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07216157
Study Brief:
Protocol Section:
NCT07216157