Enrolling by invitation NCT07118020
Post Market Study of Tutopatch In Craniotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Craniotomy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Post-Market Study of Tutopatch in Craniotomy
Overview
This is a post market prospective, multi-center study of up to 75 participants at approximately 8 clinical study sites. The objective of the study is to evaluate safety by assessing incidence of device and/or procedure related adverse events.
Primary outcome measures
- Device and/or Procedure Related Adverse Events [Time frame: 12 months]
Secondary outcome measures (2)
- Rate of cerebrospinal fluid leakage [Time frame: 12 months]
- Incidence of re-operation [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Males and females of any age undergoing craniotomy
- Able to return for scheduled study visits
- Informed consent is able to be obtained
Exclusion criteria
- Life expectancy < 12 months
- Local cerebral infection
- Previous surgery at same anatomical site
- Currently enrolled in another study that would affect validity of study
- Known hypersensitivity to bovine collagen
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Universitatsklinik fur Neurochirurgie der PMU — Salzburg
Spain · 1 center
- Hospital Universitari Vali d'Hebron — Barcelona
Identifiers
NCT: NCT07118020 · RTI-2022-02