Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy

Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy - Prospective Multi-Center Post Market Surveillance of the Efficacy and the Safety of the DuraSeal Dural Sealant System in a Craniotomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000007147

Enrollment

140

Registered

2012-01-26

Start date

2012-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients scheduled for craniotomy that entails dural incision.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients scheduled for craniotomy that entails dural incision. 2) Written informed consent is obtained from the subject or the subject's legal representative.

Exclusion criteria

Exclusion criteria: 1) Patient has active infection at surgical site. 2) Patient has impaired renal or hepatic function as diagnosed by Principal Investigator. 3) Patient has immune disorder. 4) Patient has traumatic injuries to the head. 5) Patient has dural gap exceeding 2mm. 6) Patient undergoing a contaminated cranial procedure that entails a dural incision involving perforation (other than superficial) of the sinus or mastoid air cells. 7) Patient undergoing procedures involving petrous bone drilling. 8) Patient surgery requires the use of non-autologous duraplasty materials. 9) Patient surgery requires DuraSeal application to confined bony structures where nerves are present. 10) Patient younger than 1 years of age, or in pregnant or breast feeding female. 11) Patient with a known allergy to FD&C Blue #1 dye. * All exclusion criteria are determined based on information contained in "Warnings" and "Contraindications" in the Instructions for Use.

Design outcomes

Primary

Measure	Time frame
Evaluation of Efficacy 1)Presence of CSF leakage during surgery Evaluation of Safety 1)All post-operative adverse events Focusing on the following A)Presence of post-operative CSF leak. B)Presence of suture site wound infection redness, swelling, hotness as diagnosed by Principal Investigator. C)Presence of post-operative meningitis symptoms of brain hypertension such as fever, headaches, vomiting, nuchal stiffness, Kernig's sign, evaluation by CSF test as diagnosed by Principal Investigator. 2)Malfunctions of the Product defined as any mechanical failure of a device during use that results in an inability to deliver the liquid precursors Product malfunctions do not include assembly errors.	—

Measure

Time frame

Evaluation of Efficacy 1)Presence of CSF leakage during surgery Evaluation of Safety 1)All post-operative adverse events Focusing on the following A)Presence of post-operative CSF leak. B)Presence of suture site wound infection redness, swelling, hotness as diagnosed by Principal Investigator. C)Presence of post-operative meningitis symptoms of brain hypertension such as fever, headaches, vomiting, nuchal stiffness, Kernig's sign, evaluation by CSF test as diagnosed by Principal Investigator. 2)Malfunctions of the Product defined as any mechanical failure of a device during use that results in an inability to deliver the liquid precursors Product malfunctions do not include assembly errors.

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Countries

Japan

Outcome results