Patient ParticipationNCT05537779
Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination
An observational study of Patient Participation, run by Guerbet.
Trial summary
The study is a prospective, single-arm observational multicenter clinical investigation. The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use. Read more about this study
- Who is it for?
- Ages 2 to 100 years
- Conditions the study is for
- Patient Participation
- What is being tested?
- CT examination
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Jan 2023
- 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 2 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects referred for contrast enhanced CT examination who meet the eligibility criteria
Who may be able to join
- Subject referred for a contrast-enhanced CT examination using a power injector
- Subject or legal representative for children, having provided written informed consent
Who cannot join
- Subject weighting less than 10 kg
- Pregnant or breastfeading woman subject
- Subject with known allergy or hypersensitivity to contrast media
- Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
- Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
- Subject unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Performance of Optivantage Multi-use Solution When Injecting Contrast Media to Subjects Requiring Contrast Enhanced CT Examination
The study is a prospective, single-arm observational multicenter clinical investigation.
The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.
Read the detailed description
Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System.
100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.
- Conditions
- Patient Participation
- Being tested
- CT examination
- Keywords
- Safety, Performance, Power Injector, Optivantage
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT examinationDevice
Administration of contrast medium using the power injector
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Optivantage
Rate of extravasation
Measured: Per procedure
Performance of Optivantage
Success of injection
Measured: Per procedure
Secondary outcomes (2)
Safety of Optivantage
Rate of patient complications
Measured: Per procedure
Device deficiencies
Rate of device deficiencies including malfunction and error use
Measured: Per procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient ParticipationStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537779
- Sponsor's protocol ID
- OPV-88-001
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Optivantage Multi-use Solution When Injecting Contrast Media to Subjects Requiring Contrast Enhanced CT Examination
- ClinicalTrials.gov ID
- NCT05537779
- Acronym / sponsor ID
- OPV-88-001
- Conditions
- Patient Participation
- Keywords
- Safety, Performance, Power Injector, Optivantage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 13 Sep 2022 (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 study is a prospective, single-arm observational multicenter clinical investigation.
The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.
Detailed description
Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System.
100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects referred for contrast enhanced CT examination who meet the eligibility criteria
Key inclusion criteria (2 listed)
- Subject referred for a contrast-enhanced CT examination using a power injector
- Subject or legal representative for children, having provided written informed consent
Key exclusion criteria (6 listed)
- Subject weighting less than 10 kg
- Pregnant or breastfeading woman subject
- Subject with known allergy or hypersensitivity to contrast media
- Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
- Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
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 |
|---|---|---|
| CT examinationAdministration of contrast medium using the power injector | Device | – |
Primary outcome
Safety of Optivantage
Time frame: Per procedure
Rate of extravasation
Performance of Optivantage
Time frame: Per procedure
Success of injection
2 secondary outcomes
Safety of Optivantage
Time frame: Per procedure
Device deficiencies
Time frame: Per procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Participation, run by Guerbet.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Hao, MD (+33 (0)1 45 91 51 76, jing.hao@guerbet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Optivantage (time frame: Per procedure). The study lists 2 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 13 Sep 2022.