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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03875469




Registration number
NCT03875469
Ethics application status
Date submitted
26/02/2019
Date registered
14/03/2019

Titles & IDs
Public title
Study to Test the Usability of a New Injector to Administer Contrast Media Into Humans for Diagnostic Purposes
Scientific title
Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)
Secondary ID [1] 0 0
20521
Universal Trial Number (UTN)
Trial acronym
PERCENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Computed Tomography 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Centargo injector (BPI 1000045)
Treatment: Devices - Stellant MP injector

Experimental: CT patients_Centargo_1 - Adult patients referred for contrast-enhanced computed tomography in study part 1

Experimental: CT-patients_Stellant_1 - Adult patients referred for contrast-enhanced computed tomography in study part 1

Experimental: CT-patients_Centargo_2 - Adult patients referred for contrast-enhanced computed tomography in study part 2 (includes all patients of Arm 1)


Treatment: Devices: Centargo injector (BPI 1000045)
Contrast-enhanced computer tomography conducted with Centargo injector

Treatment: Devices: Stellant MP injector
Contrast-enhanced computer tomography conducted with Stellant MP injector
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Setup time of CT systems
Timepoint [1] 0 0
1 day
Primary outcome [2] 0 0
Change time for bottle/ bag containing contrast medium
Timepoint [2] 0 0
1 day
Primary outcome [3] 0 0
Patient setup time for the multi-patient set per day
Timepoint [3] 0 0
1 day
Primary outcome [4] 0 0
Teardown time of CT-system
Timepoint [4] 0 0
1 day
Primary outcome [5] 0 0
Number of multi-patient sets per day
Timepoint [5] 0 0
1 day
Secondary outcome [1] 0 0
Total cost for multi-patients set and disposables per patient and day
Timepoint [1] 0 0
1 day
Secondary outcome [2] 0 0
Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours
Timepoint [2] 0 0
1 day
Secondary outcome [3] 0 0
Volume of unused contrast agent at teardown time
Timepoint [3] 0 0
1 day
Secondary outcome [4] 0 0
Volume of unused saline at teardown time
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
Flow rate of contrast agent through the injector
Timepoint [5] 0 0
1 day
Secondary outcome [6] 0 0
Volume of contrast agent delivered through injector
Timepoint [6] 0 0
1 day
Secondary outcome [7] 0 0
Injector-generated pressure
Timepoint [7] 0 0
1 day
Secondary outcome [8] 0 0
Number of automated system alerts
Timepoint [8] 0 0
1 day
Secondary outcome [9] 0 0
Radiographer satisfaction with contrast-media injector by study-related questionnaire
Timepoint [9] 0 0
Up to 4.5 months
Secondary outcome [10] 0 0
Number of errors requiring a CT-system reboot
Timepoint [10] 0 0
1 day

Eligibility
Key inclusion criteria
* Adult subjects referred for contrast-enhanced computer tomography using a power injector
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant and lactating women
* Subjects with know hypersensitivity to iodinated contrast media
* Subjects with unacceptable renal function per local guidelines

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/03/2020
Sample size
Target
Accrual to date
Final
425
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Medscan - Merrylands
Recruitment postcode(s) [1] 0 0
2160 - Merrylands
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Limburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03875469