ACCUvein Measure Before ULtrasound as A facilitataTION Tool for Venous Marking

Other Diseases of Veins and Lymphatics Clinical Trial

— ACCUMULATION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538080
• Other study ID #: 2018-A01101-54
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: August 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Other Diseases of Veins and Lymphatics

Intervention

Device:
• ACCUVEIN 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
• Ultrasound only
Intervention is marking with ultrasound imaging as in usual practice.

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to perform the saphenous vein marking with AccuVein® system	Time 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.	inclusion
Secondary	Degree of satisfaction of the vascular physician and the surgeon	Likert 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	inclusion
Secondary	Rate of consumables	Number of marker pens needed during marking, according to the use of AccuVein® or the ultrasound doppler reference technique for the detection of saphenous veins	inclusion