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

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

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.

Study Overview

• Status: Completed
• Conditions: Other Diseases of Veins and Lymphatics
• Intervention / Treatment: Device: ACCUVEIN plus ultrasound; Device: Ultrasound only

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49100
    • UH Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACCUVEIN plus ultrasound; 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	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
SHAM_COMPARATOR: Ultrasound only; 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.	Device: Ultrasound only; Intervention is marking with ultrasound imaging as in usual practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: HENNI MD SAMIR, PhD, UH Angers

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): June 20, 2019
• Study Completion (ACTUAL): June 20, 2019

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (ACTUAL): May 25, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: ultrasound imaging; peripheral vascular disease; vascular surgery; venous disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: 2018-A01101-54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No