The CUSA Clarity Bone Tip Study

Integra LifeSciences

Status

Withdrawn

Conditions

Cranial Skull Base Bone Removal

Treatments

Device: CUSABT

Study type

Observational

Funder types

Industry

Identifiers

NCT04300075

C-CUSABT-001

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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