Retrospective, Single Center, Single Arm Post Market Clinical Follow-Up (PMCF) Study on the Performance and Safety of Lyoplant® Used for the Replacement and Extension of Connective Tissue Structures in Neurosurgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aesculap AG
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Rate of Cerebrospinal Fluid Leakage
Study Overview
Brief Summary
Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years
- •Use of investigational device according to Instructions for Use (IfU)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of Cerebrospinal Fluid Leakage
Time Frame: at one follow-up ≥ 3 months after surgery
A Cerebrospinal Fluid (CSF) leakage needs to be confirmed by radiological image evaluation (computed tomography scan, CT or magnetic resonance imaging scan, MRI). It will be documented if the CSF leak was clinically evident or not. A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice (e.g., rhinorrhea or otorrhea) or as subcutaneous visible and / or palpable fluid accumulation next to or at the site of surgical incision suspected to be CSF. A non-clinically evident CSF leak is defined as CSF accumulation which could be detected only by radiological image evaluation (CT / MRI).
Secondary Outcomes
- Incidence of re-operations with product relationship(at one follow-up ≥ 3 months after surgery)
- Incidence of further (serious) adverse events in chronologic sequence(intra- and postoperative, until follow-up ≥ 3 months after surgery)