ACCUvein Measure Before ULtrasound as A facilitataTION Tool for Venous Marking (ACCUMULATION)

University Hospital, Angers

Status: Completed

Conditions: Other Diseases of Veins and Lymphatics

Treatments: Device: ACCUVEIN plus ultrasound; Device: Ultrasound only

Study type: Interventional

Funder types: Other

Identifiers

NCT03538080

2018-A01101-54

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

ACCUVEIN plus ultrasound

Experimental group

Description:

Patients referred for marking of saphenous veins before varicose vein surgery or for saphenectomy for vascular or coronary artery bypass grafting will have marking with Accuvein and ultrasound

Treatment:

Device: ACCUVEIN plus ultrasound

Ultrasound only

Sham Comparator group

Description:

Patients referred for marking of saphenous veins before varicose vein surgery or for saphenectomy for vascular or coronary artery bypass grafting will have marking with ultrasound only.

Treatment:

Device: Ultrasound only