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ACCUvein Measure Before ULtrasound as A facilitataTION Tool for Venous Marking

Evaluation du pré-marquage Par AccuVein® au Cours Des échographies Doppler de repérage saphène.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03538080
Acronym
ACCUMULATION
Enrollment
50
Registered
2018-05-25
Start date
2018-09-03
Completion date
2019-06-20
Last updated
2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Diseases of Veins and Lymphatics

Keywords

venous disease, peripheral vascular disease, vascular surgery, ultrasound imaging

Brief summary

Ultrasound marking of saphenous veins before varicose vein surgery or for saphenectomy for vascular or coronary artery bypass grafting is a long, tedious, low-grading examination, generating overconsumption of many consumables including marking markers that may damage the probes, of the modern and expensive ultrasound doppler. Augmented reality devices can visualize the superficial veins and hope to simplify the investigation, improve the comfort of the patient during the examination by significantly reducing the time of the examination. There is few data in the literature on the value of using augmented reality devices of this type. The AccuVein® system is a patient-friendly, non-contact, non-invasive technique that minimizes discomfort due to standing time and thus improves patient comfort.

Detailed description

At admission eligible patients are proposed to participate. Written consent is signed after complete oral and written explanation of the protocol is signed. No register of non-included patients will be kept. In included patients, in parallel to the standard ultrasound investigation for marking of saphenous veins for which the patient is referred, AccuVein® system will be performed as explained later in arm description. Usual ongoing treatments are obtained by history and recorded. The end of the visit is the end of the participation of the subjects.

Interventions

DEVICEACCUVEIN plus ultrasound

Intervention is marking of the saphenous veins with ACCUVEIN system. The AccuVein® AV400 vein illumination system is a laser imaging system that detects superficial veins up to 10 mm deep and digitally displays, through a projected red light, a map of the vascularization on the surface of the skin. in real time, allowing clinicians to check vein permeability and position. This system is portable and lightweight. It can be easily cleaned, and requires no calibration or adjustment. It does not require any contact with the patient. Second time is completion of marking by ultrasound if necessary

Intervention is marking with ultrasound imaging as in usual practice.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients referred for venous marking * Affiliation to the French National healthcare system * French speaking patients

Exclusion criteria

* pregnancy * inability to understand the study goal * patients protected by decision of law

Design outcomes

Primary

MeasureTime frameDescription
Time to perform the saphenous vein marking with AccuVein® systeminclusionTime to perform the marking of the leg (from the beginning of marking until the end of marking of the leg concerned), using the AccuVein® system supplemented by a ultrasound doppler , compared to the ultrasound doppler reference technique.

Secondary

MeasureTime frameDescription
Degree of satisfaction of the vascular physician and the surgeoninclusionLikert scale of satisfaction of the surgeon and the vascular physician, according to the use of AccuVein® or the ultrasound doppler reference technique for the identification of saphenous veins
Rate of consumablesinclusionNumber of marker pens needed during marking, according to the use of AccuVein® or the ultrasound doppler reference technique for the detection of saphenous veins

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026