Patient Who Are Difficult to InfuseVAV-AVNCT06861595
Using the Accuvein Device for Patients Who Are Difficult to Perfuse
A study testing accuvein and with out accuvein in people with Patient Who Are Difficult to Infuse, run by University Hospital, Rouen at 1 site in France.
Trial summary
Prior to any examination related to the clinical investigation, the investigator (IDE) will check the eligibility criteria of the person undergoing the research, and will inform and obtain the free, informed and written consent of the person undergoing the research. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Who Are Difficult to Infuse
- What is being tested?
- accuvein and with out accuvein
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Patients who are difficult to infuse according to the nurse's subjective assessment after the tourniquet has been applied; this may particularly concern patients who are obese, dark-skinned, multi-drug users, sickle-cell anaemia sufferers, drug addicts, elderly with fragile skin and subcutaneous haematomas
- Patients with a medical prescription for intravenous route
- Patients affiliated to a social security scheme
- For women of childbearing age: effective contraception (oral contraceptives, intra-uterine devices or condoms) or post-menopausal women (no menstrual period for 12 months).
- Patient has read and understood the information letter and signed the consent form
Who cannot join
- Contraindication to fitting a intravenous route (burns to all four limbs, etc.)
- Extreme urgency to have a intravenous route, incompatible with the study, because of a loss of chance due to loss of time
- Patients unable to consent to participation in research
- Pregnant or breastfeeding women or women in labour
- Person deprived of liberty by administrative or judicial decision or person placed under court protection/guardianship or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chu Rouen
Rouen, Rouen, 76 031
jessica bortzmeyer, nurse, 02 32 88 86 94, jessica.bortzmeyer@chu-rouen.fr
jessica bortzmeyer, nurse
About this study
Prior to any examination related to the clinical investigation, the investigator (IDE) will check the eligibility criteria of the person undergoing the research, and will inform and obtain the free, informed and written consent of the person undergoing the research.
The patient will then be randomised into one of two groups (insertion of a intravenous route with the AccuVein device vs. insertion of a VVP without the AccuVein device). After randomisation, the TEC or qualified person starts the stopwatch as soon as the tourniquet is applied.
Read more
The nurse makes a first attempt to perfuse the patient. The TEC or the qualified person will stop the stopwatch when the nurse checks the patency of the first attempt at perfusion and signals its success, or when the nurse withdraws the needle if the first attempt is unsuccessful. The pain felt by the patient will be assessed by the nurse using the self-assessment scale from 0 to 10 at the end of the first attempt.
If the first attempt at VVP insertion fails, the choice of conditions and personnel involved in carrying out further attempts will be left to the discretion of the nurse.
- Conditions
- Patient Who Are Difficult to Infuse
- Being tested
- accuvein, with out accuvein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accuveinDevice
intravenous route with accuvein
with out accuveinOther
intravenous route with out accuvein
| Study group | Role | What they receive |
|---|---|---|
| accuvein | Experimental | Not described Receives: Device: accuvein |
| with out accuvein | Other | Not described Receives: Other: with out accuvein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful first attempt at intravenous route insertion defined by a functional perfusion placed in a vein
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Who Are Difficult to InfuseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861595
- Sponsor's protocol ID
- 2022/0357/HP
- Acronym
- VAV-AV
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Accuvein Device for Patients Who Are Difficult to Perfuse
- ClinicalTrials.gov ID
- NCT06861595
- Acronym / sponsor ID
- VAV-AV / 2022/0357/HP
- Conditions
- Patient Who Are Difficult to Infuse
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Mar 2025 (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.
Prior to any examination related to the clinical investigation, the investigator (IDE) will check the eligibility criteria of the person undergoing the research, and will inform and obtain the free, informed and written consent of the person undergoing the research.
The patient will then be randomised into one of two groups (insertion of a intravenous route with the AccuVein device vs. insertion of a VVP without the AccuVein device). After randomisation, the TEC or qualified person starts the stopwatch as soon as the tourniquet is applied.
The nurse makes a first attempt to perfuse the patient. The TEC or the qualified person will stop the stopwatch when the nurse checks the patency of the first attempt at perfusion and signals its success, or when the nurse withdraws the needle if the first attempt is unsuccessful. The pain felt by the patient will be assessed by the nurse using the self-assessment scale from 0 to 10 at the end of the first attempt.
If the first attempt at VVP insertion fails, the choice of conditions and personnel involved in carrying out further attempts will be left to the discretion of the nurse.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| accuvein | Experimental | Device: accuvein |
| with out accuvein | Other | Other: with out accuvein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Patients who are difficult to infuse according to the nurse's subjective assessment after the tourniquet has been applied; this may particularly concern patients who are obese, dark-skinned, multi-drug users, sickle-cell anaemia sufferers, drug addicts, elderly with fragile skin and subcutaneous haematomas
- Patients with a medical prescription for intravenous route
- Patients affiliated to a social security scheme
- For women of childbearing age: effective contraception (oral contraceptives, intra-uterine devices or condoms) or post-menopausal women (no menstrual period for 12 months).
Key exclusion criteria (5 listed)
- Contraindication to fitting a intravenous route (burns to all four limbs, etc.)
- Extreme urgency to have a intravenous route, incompatible with the study, because of a loss of chance due to loss of time
- Patients unable to consent to participation in research
- Pregnant or breastfeeding women or women in labour
- Person deprived of liberty by administrative or judicial decision or person placed under court protection/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 |
|---|---|---|
| accuveinintravenous route with accuvein | Device | accuvein |
| with out accuveinintravenous route with out accuvein | Other | with out accuvein |
Primary outcome
Successful first attempt at intravenous route insertion defined by a functional perfusion placed in a vein
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accuvein and with out accuvein in people with Patient Who Are Difficult to Infuse, run by University Hospital, Rouen 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jessica bortzmeyer, nurse (02 32 88 86 94, jessica.bortzmeyer@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful first attempt at intravenous route insertion defined by a functional perfusion placed in a vein (time frame: day 1). 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 20 Feb 2026.