The CUSA Clarity Bone Tip Study

Launched by INTEGRA LIFESCIENCES CORPORATION · Mar 6, 2020

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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