The CUSA Clarity Bone Tip Study
Withdrawn
- Conditions
- Cranial Skull Base Bone Removal
- Interventions
- Device: CUSABT
- Registration Number
- NCT04300075
- Lead Sponsor
- Integra LifeSciences Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 exclusion criteria :
- Surgeon does not utilize CUSA Clarity Bone Tip for cranial skull base bone removal during surgery or utilizes CUSA Clarity Bone Tip anywhere else besides the cranial skull base
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CUSABT CUSABT Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery
- Primary Outcome Measures
Name Time Method 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))
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Ospedale di Treviso
🇮🇹Treviso, Italy
General Hospital of Athens "Georgios Gennimatas"
🇬🇷Athens, Greece
Azienda Sanitaria Universitaria Integrata di Udine
🇮🇹Udine, Italy
St. Barbara-Klinik Hamm-Heessen Klinik für Neurochirurgie
🇩🇪Hamm, Germany
Universitätsklinikum Münster Klinik und Poliklinik für Neurochirurgie
🇩🇪Münster, Germany
Azienda Ospedaliero-Universitaria Consorziale Policlinico
🇮🇹Bari, Italy