Computed TomographyPERCENTNCT03875469
Study to Test the Usability of a New Injector to Administer Contrast Media Into Humans for Diagnostic Purposes
A study testing Centargo injector (BPI 1000045) and Stellant MP injector in people with Computed Tomography, run by Bayer at 2 sites in 2 countries.
Trial summary
This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computed Tomography
- What is being tested?
- Centargo injector (BPI 1000045) and Stellant MP injector
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 425 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jun 2019to 10 Mar 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adult subjects referred for contrast-enhanced computer tomography using a power injector
Who cannot join
- Pregnant and lactating women
- Subjects with know hypersensitivity to iodinated contrast media
- Subjects with unacceptable renal function per local guidelines
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229
About this study
Official title: Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)
This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.
Read the detailed description
The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).
- Conditions
- Computed Tomography
- Being tested
- Centargo injector (BPI 1000045), Stellant MP injector
- Keywords
- Contrast-enhanced computed tomography (CECT), Injector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centargo injector (BPI 1000045)Device
Contrast-enhanced computer tomography conducted with Centargo injector
Stellant MP injectorDevice
Contrast-enhanced computer tomography conducted with Stellant MP injector
| Study group | Role | What they receive |
|---|---|---|
| CT patients_Centargo_1 | Experimental | Adult patients referred for contrast-enhanced computed tomography in study part 1 Receives: Device: Centargo injector (BPI 1000045) |
| CT-patients_Stellant_1 | Experimental | Adult patients referred for contrast-enhanced computed tomography in study part 1 Receives: Device: Stellant MP injector |
| CT-patients_Centargo_2 | Experimental | Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1) Receives: Device: Centargo injector (BPI 1000045) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Setup time of CT systems
Measured: 1 day
Change time for bottle/ bag containing contrast medium
Measured: 1 day
Patient setup time for the multi-patient set per day
Measured: 1 day
Teardown time of CT-system
Measured: 1 day
Number of multi-patient sets per day
Measured: 1 day
Secondary outcomes (10)
Total cost for multi-patients set and disposables per patient and day
Measured: 1 day
Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours
Measured: 1 day
Volume of unused contrast agent at teardown time
Measured: 1 day
Volume of unused saline at teardown time
Measured: 1 day
Flow rate of contrast agent through the injector
Measured: 1 day
Volume of contrast agent delivered through injector
Measured: 1 day
Injector-generated pressure
Measured: 1 day
Number of automated system alerts
Incl. alerts due to communication loss, pressure limiting, air detection (Centargo only) and a full waste container (Centrago only).
Measured: 1 day
Radiographer satisfaction with contrast-media injector by study-related questionnaire
Questionnaire contains 14 questions on injectors, disposables and software, pertaining to 5 levels of user satisfaction (´Very easy´ to ´Very hard´). Levels of user satisfaction from different questions are not combined.
Measured: Up to 4.5 months
Number of errors requiring a CT-system reboot
For Centargo only (Part 2)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start21 Jun 2019
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computed TomographyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875469
- Sponsor's protocol ID
- 20521
- Acronym
- PERCENT
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)
- ClinicalTrials.gov ID
- NCT03875469
- Acronym / sponsor ID
- PERCENT / 20521
- Conditions
- Computed Tomography
- Keywords
- Contrast-enhanced computed tomography (CECT), Injector
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 14 Mar 2019 (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.
This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.
Detailed description
The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT patients_Centargo_1 | Experimental | Device: Centargo injector (BPI 1000045)Adult patients referred for contrast-enhanced computed tomography in study part 1 |
| CT-patients_Stellant_1 | Experimental | Device: Stellant MP injectorAdult patients referred for contrast-enhanced computed tomography in study part 1 |
| CT-patients_Centargo_2 | Experimental | Device: Centargo injector (BPI 1000045)Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects referred for contrast-enhanced computer tomography using a power injector
Key exclusion criteria (3 listed)
- Pregnant and lactating women
- Subjects with know hypersensitivity to iodinated contrast media
- Subjects with unacceptable renal function per local guidelines
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 |
|---|---|---|
| Centargo injector (BPI 1000045)Contrast-enhanced computer tomography conducted with Centargo injector | Device | CT patients_Centargo_1, CT-patients_Centargo_2 |
| Stellant MP injectorContrast-enhanced computer tomography conducted with Stellant MP injector | Device | CT-patients_Stellant_1 |
Primary outcome
Setup time of CT systems
Time frame: 1 day
Change time for bottle/ bag containing contrast medium
Time frame: 1 day
Patient setup time for the multi-patient set per day
Time frame: 1 day
Teardown time of CT-system
Time frame: 1 day
Number of multi-patient sets per day
Time frame: 1 day
10 secondary outcomes
Total cost for multi-patients set and disposables per patient and day
Time frame: 1 day
Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours
Time frame: 1 day
Volume of unused contrast agent at teardown time
Time frame: 1 day
Volume of unused saline at teardown time
Time frame: 1 day
Flow rate of contrast agent through the injector
Time frame: 1 day
Volume of contrast agent delivered through injector
Time frame: 1 day
Injector-generated pressure
Time frame: 1 day
Number of automated system alerts
Time frame: 1 day
Radiographer satisfaction with contrast-media injector by study-related questionnaire
Time frame: Up to 4.5 months
Number of errors requiring a CT-system reboot
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Centargo injector (BPI 1000045) and Stellant MP injector in people with Computed Tomography, run by Bayer at 2 sites in 2 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Setup time of CT systems (time frame: 1 day). The study lists 5 primary outcomes in all. 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 3 Mar 2021.