The CUSA Clarity Bone Tip Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cranial Skull Base Bone Removal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CUSABT

Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery

CUSABT

Intervention Type DEVICE

Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery

Interventions

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CUSABT

Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No