CClinicalTrials.gg
Status unknownNCT03996135CIRRVVUSUpdated Aug 24, 2022

Evaluation of Accuvein in Cirrhotics Patients

An interventional study of Cannulation with AccuVein AV400 in Liver Cirrhosis, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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®.

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Conditions studied

  • Liver Cirrhosis

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03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's planned enrollment of 280 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patient under 18 years old
  • Patient unable to give consent
  • Patient under guardianship or curatorship
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Study design

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

Study arms

  • Experimental
    Experimental : Cannulation with AccuVein AV400

    Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation

    Device: Cannulation with AccuVein AV400

  • No intervention
    Control

    Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.

Interventions

  • DeviceCannulation with AccuVein AV400

    Cannulation using AccuVein AV400 device

    Also known as: AccuVein AV400

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

Secondary outcomes

  1. change of the score A-DIVA

    Scores A-DIVA between beginning and end of hospitalization between the two groups

    Time frame: baseline and end of hospitalization (up to a month)

  2. Cost

    Cost of consumables used in euro between the two groups

    Time frame: baseline

  3. Life expectancy of the catheter

    Life expectancy of the catheter between the two groups

    Time frame: baseline

  4. Utilisation of a central venous catheter

    Use of a central venous catheter (y/n)

    Time frame: baseline

  5. Pain's score

    visual analogic scale

    Time frame: baseline

  6. Numbers of attempts

    Number of attempts between two groups

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03996135
Lead sponsor
University Hospital, Caen
Responsible party
Sponsor
First posted
Jun 24, 2019
Start date
Jun 15, 2020
Primary completion
Jun 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Aug 24, 2022

Study contacts

Philippe Moiteaux
Contact
moiteaux-p@chu-caen.fr
0231064542
Nelly Orliac
Contact
orliac-n@chu-caen.fr
0231063082

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 status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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