Cranial Skull Base Bone RemovalNCT04300075
The CUSA Clarity Bone Tip Study
An observational study of Cranial Skull Base Bone Removal, run by Integra LifeSciences Corporation at 6 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Skull Base Bone Removal
- What is being tested?
- CUSABT
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2023to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject requiring a cranial skull base procedure involving removal of bone with a ultrasonic aspirator
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Italy3 sites
Azienda Ospedaliero-Universitaria Consorziale Policlinico
Bari
Ospedale di Treviso
Treviso
Azienda Sanitaria Universitaria Integrata di Udine
Udine
Germany2 sites
St. Barbara-Klinik Hamm-Heessen Klinik für Neurochirurgie
Hamm
Universitätsklinikum Münster Klinik und Poliklinik für Neurochirurgie
Münster
About this study
Official title: 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.
- Conditions
- Cranial Skull Base Bone Removal
- Being tested
- CUSABT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSABTDevice
Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery
| Study group | Role | What they receive |
|---|---|---|
| CUSABT | Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery Receives: Device: CUSABT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: Surgery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study startJun 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Why it stopped: Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial Skull Base Bone RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Marzuola, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300075
- Sponsor's protocol ID
- C-CUSABT-001
- Status last verified
- Aug 2023
- First submitted
- 5 Mar 2020
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance Investigation of the CUSA Clarity Bone Tip for Cranial Skull Base Bone Removal Procedures
- ClinicalTrials.gov ID
- NCT04300075
- Acronym / sponsor ID
- C-CUSABT-001
- Conditions
- Cranial Skull Base Bone Removal
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Business Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUSABT | – | Device: CUSABTSubject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject requiring a cranial skull base procedure involving removal of bone with a ultrasonic aspirator
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUSABTSubject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery | Device | CUSABT |
Primary outcome
Effectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale
Time frame: Surgery time
Multifactorial 5-point Likert scale (1 (worst) to 5 (best))
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Cranial Skull Base Bone Removal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Marzuola study director
Integra LifeSciences
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cranial Skull Base Bone Removal, run by Integra LifeSciences Corporation at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Germany, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of bone removal to access lesion per surgeon assessment: Multifactorial 5-point Likert scale (time frame: Surgery time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.