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Not yet recruitingNCT06861595VAV-AVUpdated Feb 20, 2026

Using the Accuvein Device for Patients Who Are Difficult to Perfuse

An interventional study of accuvein and with out accuvein in Patient Who Are Difficult to Infuse, sponsored by University Hospital, Rouen. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Patient Who Are Difficult to Infuse
03

In context

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    accuvein

    Device: accuvein

  • Other
    with out accuvein

    Other: with out accuvein

Interventions

  • Deviceaccuvein

    intravenous route with accuvein

  • Otherwith out accuvein

    intravenous route with out accuvein

06

What researchers measure

Primary outcomes

  1. Successful first attempt at intravenous route insertion defined by a functional perfusion placed in a vein

    Time frame: day 1

07

Study locations

1 site
  • Chu Rouen
    Rouen, Rouen 76 031, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06861595
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Mar 6, 2025
Start date
Mar 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Feb 20, 2026

Study contacts

jessica bortzmeyer, nurse
Contact
jessica.bortzmeyer@chu-rouen.fr
02 32 88 86 94
déborah lebedieff
Contact
deborah.lebedieff@chu-rouen.fr
0232888265

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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