NCT07927413 Effectiveness and Safety of TachoSil® Fibrin Sealant Patch for Supporting Dural Sealing Among Adult Inpatients
| NCT ID | NCT07927413 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corza Medical GmbH |
| Condition | Cerebrospinal Fluid (CSF) Leak |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2026-02-13 |
| Primary Completion | 2026-11-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2026-02-13 with a primary completion date of 2026-11-16.
⚠ 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
This retrospective observational cohort study compares the effectiveness and safety of adjunctive TachoSil® fibrin sealant patch with DuraSeal® hydrogel sealant for supporting dural sealing in adult patients undergoing cranial or spinal surgery at participating United States hospitals. Medical records will be reviewed to assess clinically evident cerebrospinal fluid leak or clinically evident pseudomeningocele within 90 days after surgery. The study will use 1:1 propensity score matching to evaluate whether TachoSil® is non-inferior to DuraSeal® and will assess additional effectiveness and safety outcomes.
Eligibility Criteria
Inclusion Criteria: * Aged ≥ 18 years * Had an inpatient encounter to select sites with a cranial or spinal neurological surgery that involves dural sealing performed and discharged during January 1, 2017, and March 31, 2026 * Had use of TachoSil® or DuraSeal® sealants during the cranial or spinal neurological surgery as supportive dural sealing method Note: Any surgery meeting the above criteria is considered index surgery Exclusion Criteria: * Index surgery was trauma-related * Had an infection within 7 days prior to index date * Had any neurosurgery involving dural opening during the 12-month look-back period * Had neoplasm of dura mater/meningioma, requiring resection of dura during index visit (the earliest visit meeting selection criteria) or 12-month look-back period * Was pregnant at index visit * Had a CSF leak during the 12-month look-back period * If the surgical approach was transbasal or transpetrosal, if the arachnoid membrane and CSF- containing system remained intact, or if there was \>1 dura opening (excluding extra ventricular or lumbar drains) during index surgery * Had use of Evarrest patch, Tisseel, Adherus, CraniSeal, Duragen, fibrin glue or other dural sealing products during index surgery * Had radiation therapy to surgical field in the 3 months prior to index date * Had chronic corticosteroid use in the 3 months prior to index date * Had both TachoSil® and DuraSeal® used for dural closure during index neurological surgery
Contact & Investigator
Ning Rosenthal, MD, PhD, MPH,
PRINCIPAL INVESTIGATOR
Premier Inc
Frequently Asked Questions
Who can join the NCT07927413 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebrospinal Fluid (CSF) Leak. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07927413 currently recruiting?
Yes, NCT07927413 is actively recruiting participants. Contact the research team at Jeff.Wilson@corza.com for enrollment information.
Where is the NCT07927413 trial being conducted?
This trial is being conducted at Baltimore, United States, New York, United States, Cincinnati, United States, Philadelphia, United States and 2 additional locations.
Who is sponsoring the NCT07927413 clinical trial?
NCT07927413 is sponsored by Corza Medical GmbH. The principal investigator is Ning Rosenthal, MD, PhD, MPH, at Premier Inc. The trial plans to enroll 600 participants.