Effectiveness and Safety of TachoSil® Fibrin Sealant Patch for Supporting Dural Sealing Among Adult Inpatients
NCT07927413, Recruiting, Corza Medical GmbH
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness and Safety of TachoSil® Fibrin Sealant Patch for Supporting Dural Sealing Among Adult Inpatients | ClinicalTrials.gov |
| NCT number | NCT07927413 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 600 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Corza Medical GmbH | ClinicalTrials.gov |
| Conditions | Cerebrospinal Fluid (CSF) Leak, Psuedomeningocele | ClinicalTrials.gov |
| Interventions | TachoSil®, DuraSeal® | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele | Within 90 days post surgery | A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice verified by a glucose concentration test or β-2 transferrin test. A clinically evident pseudomeningocele is defined as a subcutaneous visible and/or palpable fluid accumulation adjacent to or at the site of surgical incision suspected to be CSF. If there is not a collection of CSF/pseudomeningocele, or active leak that can be sampled for β-2 transferrin test, but the participant had symptoms consistent with intracranial hypotension and/or an ex vacuo type subdural hematoma, the participant will be considered as having clinically evident CSF leak or pseudomeningocele. | ClinicalTrials.gov |
| Secondary | Risk of Non-clinically Evident Pseudomeningocele Without Occurrence of the Primary Endpoint | Within 90 days post surgery | Non-clinically evident pseudomeningocele is defined as CSF accumulation detected only by computed tomography (CT) or magnetic resonance imaging (MRI) scan. | ClinicalTrials.gov |
| Secondary | Number of Participants Experiencing Adverse Events (AEs) and Serious AEs (SAEs) | Within 90 days post surgery | AEs refer to any undesirable event that is documented in a site's Electronic Medical Records (EMR) for an eligible participant as occurring within 90 days of the index surgery regardless of whether or not the events were considered causally related to TachoSil® or DuraSeal® use. SAEs refer to any AE documented in a site's EMR for an eligible patient that results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Individual prespecified AEs and the composite categories of any expected AE and any unexpected AE will be summarized by treatment cohort. | ClinicalTrials.gov |
| Secondary | Risk of Clinically Evident CSF Leak | Within 90 days post surgery | A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice verified by a glucose concentration test or β-2 transferrin test. | ClinicalTrials.gov |
| Secondary | Risk of Clinically Evident Pseudomeningocele | Within 90 days post surgery | A clinically evident pseudomeningocele is defined as a subcutaneous visible and/or palpable fluid accumulation adjacent to or at the site of surgical incision suspected to be CSF. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)