Cranial Skull Base Bone Removal
Conditions
Brief summary
The aim of the Study is to investigate the clinical performance and surgeon preferences of the CUSA Clarity Bone Tip during skull base surgery with removal of bony, and other cranial calcified tissue.
Interventions
DEVICECUSABT
Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years of age * Subject requires a cranial skull base procedure involving removal of bone with ultrasonic aspirator * Subject is an appropriate candidate to receive use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery, per the study surgeon * Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures
Exclusion criteria
* Subject is currently pregnant or plans to become pregnant prior to the study index surgery * Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation * Subject's surgical plan includes utilizing CUSA Clarity Bone Tip for bone removal anywhere besides the cranial skull base in an open craniotomy (e.g. transsphenoidal approach or spinal procedures). * Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee. Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale | Surgery time | Multifactorial 5-point Likert scale (1 (worst) to 5 (best)) |
Countries
Germany, Greece, Italy
Outcome results
None listed