Cranial Skull Base Bone Removal Clinical Trial
Official title:
Clinical Performance Investigation of the CUSA Clarity Bone Tip for Cranial Skull Base Bone Removal Procedures
| NCT number | NCT04300075 |
| Other study ID # | C-CUSABT-001 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2023 |
| Est. completion date | August 2024 |
| Verified date | August 2023 |
| Source | Integra LifeSciences Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2024 |
| Est. primary completion date | August 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | St. Barbara-Klinik Hamm-Heessen Klinik für Neurochirurgie | Hamm | |
| Germany | Universitätsklinikum Münster Klinik und Poliklinik für Neurochirurgie | Münster | |
| Greece | General Hospital of Athens "Georgios Gennimatas" | Athens | |
| Italy | Azienda Ospedaliero-Universitaria Consorziale Policlinico | Bari | |
| Italy | Ospedale di Treviso | Treviso | |
| Italy | Azienda Sanitaria Universitaria Integrata di Udine | Udine |
| Lead Sponsor | Collaborator |
|---|---|
| Integra LifeSciences Corporation |
Germany, Greece, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale | Multifactorial 5-point Likert scale (1 (worst) to 5 (best)) | Surgery time |