Liver CirrhosisCIRRVVUSNCT03996135
Evaluation of Accuvein in Cirrhotics Patients
A study testing Cannulation with AccuVein AV400 in people with Liver Cirrhosis, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Cannulation with AccuVein AV400
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2020to 30 Jun 2023
- 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
- Patient older than 18 years old
- Patient presenting a liver cirrhosis
- Patient requiring the placement of a venous peripheral catheter
- Patient informed and giving free and informed consent
- Patient affiliated to a French social security scheme
Who cannot join
- Patient under 18 years old
- Patient unable to give consent
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen University Hospital
Caen, 14033
Philippe Moiteaux, +33231063106, moiteaux-p@chu-caen.fr
Clémence Tomadesso, +33231065386, tomadesso-c@chu-caen.fr
About this study
Official title: Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients
The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.
- Conditions
- Liver Cirrhosis
- Being tested
- Cannulation with AccuVein AV400
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannulation with AccuVein AV400Device
Also called AccuVein AV400
Cannulation using AccuVein AV400 device
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Cannulation with AccuVein AV400 | Experimental | Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation Receives: Device: Cannulation with AccuVein AV400 |
| Control | No intervention | Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt Success Rate of Cannulation
Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.
Measured: baseline
Secondary outcomes (6)
change of the score A-DIVA
Scores A-DIVA between beginning and end of hospitalization between the two groups
Measured: baseline and end of hospitalization (up to a month)
Cost
Cost of consumables used in euro between the two groups
Measured: baseline
Life expectancy of the catheter
Life expectancy of the catheter between the two groups
Measured: baseline
Utilisation of a central venous catheter
Use of a central venous catheter (y/n)
Measured: baseline
Pain's score
visual analogic scale
Measured: baseline
Numbers of attempts
Number of attempts between two groups
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start15 Jun 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996135
- Sponsor's protocol ID
- 19-043
- Acronym
- CIRRVVUS
- Status last verified
- Jul 2022
- First submitted
- 5 Jun 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT03996135
- Acronym / sponsor ID
- CIRRVVUS / 19-043
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 24 Jun 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.
The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : Cannulation with AccuVein AV400 | Experimental | Device: Cannulation with AccuVein AV400Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation |
| Control | No intervention | –Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient older than 18 years old
- Patient presenting a liver cirrhosis
- Patient requiring the placement of a venous peripheral catheter
- Patient informed and giving free and informed consent
- Patient affiliated to a French social security scheme
Key exclusion criteria (3 listed)
- Patient under 18 years old
- Patient unable to give consent
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Cannulation with AccuVein AV400Also: AccuVein AV400Cannulation using AccuVein AV400 device | Device | Experimental : Cannulation with AccuVein AV400 |
Primary outcome
First Attempt Success Rate of Cannulation
Time frame: baseline
Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.
6 secondary outcomes
change of the score A-DIVA
Time frame: baseline and end of hospitalization (up to a month)
Cost
Time frame: baseline
Life expectancy of the catheter
Time frame: baseline
Utilisation of a central venous catheter
Time frame: baseline
Pain's score
Time frame: baseline
Numbers of attempts
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannulation with AccuVein AV400 in people with Liver Cirrhosis, run by University Hospital, Caen at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Moiteaux (0231064542, moiteaux-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Attempt Success Rate of Cannulation (time frame: baseline). 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 24 Aug 2022.