RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing TachoSil® for Cerebrospinal Fluid (CSF) Leak

This retrospective watch-and-measure (no experimental treatment required) cohort study compares the effectiveness and safety of added on top of your current treatment 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.

Official registry: https://clinicaltrials.gov/study/NCT07927413 · Corza Medical GmbH · enrollment listed as 600

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 600 people at 6 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.

Official title (unrewritten)

Effectiveness and Safety of TachoSil® Fibrin Sealant Patch in Comparison to a Hydrogel Sealant for Supporting Dural Sealing Among Adult Inpatients in the United States: A Retrospective, Non-Inferiority, Cohort Study

Interventions: TachoSil®, DuraSeal®

Primary outcome (registry wording): Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele

Who it is for (from inclusion criteria)

Ages 18 Years to any
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

Who the registry excludes

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

Public study contact (from the registry)

Jeff Wilson

416-578-9058

Jeff.Wilson@corza.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

6 listed

Johns Hopkins University — Baltimore, Maryland (recruiting)
Columbia University — New York, New York (recruiting)
University of Cincinnati College of Medicine — Cincinnati, Ohio (recruiting)
Thomas Jefferson University — Philadelphia, Pennsylvania (recruiting)
Alleghany Health Network — Pittsburgh, Pennsylvania (recruiting)
Swedish Health Services — Seattle, Washington (recruiting)

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FAQ about this NCT record

Is NCT07927413 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07927413?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07927413?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary