Post Market Study of Tutopatch In Craniotomy
Not yet recruiting
- Conditions
- Craniotomy
- Registration Number
- NCT07118020
- Lead Sponsor
- RTI Surgical
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 75
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device and/or Procedure Related Adverse Events 12 months
- Secondary Outcome Measures
Name Time Method Rate of cerebrospinal fluid leakage 12 months Incidence of re-operation 12 months