The CUSA Clarity Bone Tip Study

Clinical Performance Investigation of the CUSA Clarity Bone Tip for Cranial Skull Base Bone Removal Procedures

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.

Study Overview

• Status: Withdrawn
• Conditions: Cranial Skull Base Bone Removal
• Intervention / Treatment: Device: CUSABT

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Joshua Dilworth; Phone Number: +1 609 789-2310; Email: joshua.dilworth@integralife.com
• Study Contact Backup: Name: Andrew Tummon; Phone Number: +1 6099365490; Email: andrew.tummon@integralife.com

Study Locations

• Germany
  • Hamm, Germany
    • St. Barbara-Klinik Hamm-Heessen Klinik für Neurochirurgie
  • Münster, Germany
    • Universitätsklinikum Münster Klinik und Poliklinik für Neurochirurgie
    • Contact: Suero Molina
• Greece
  • Athens, Greece
    • General Hospital of Athens "Georgios Gennimatas"
    • Contact: Nikolas Georgakoulias
• Italy
  • Bari, Italy
    • Azienda Ospedaliero-Universitaria Consorziale Policlinico
    • Contact: Francesco Signorelli
  • Treviso, Italy
    • Ospedale di Treviso
    • Contact: Giuseppe Canova
  • Udine, Italy
    • Azienda Sanitaria Universitaria Integrata di Udine
    • Contact: Miran Skrap

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subject requiring a cranial skull base procedure involving removal of bone with a ultrasonic aspirator

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CUSABT; Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery	Device: CUSABT; Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Jason Marzuola, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: C-CUSABT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes