ACCUvein Measure Before ULtrasound as A facilitataTION Tool for Venous Marking

NCT ID: NCT03538080

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-06-20

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.

Conditions

Other Diseases of Veins and Lymphatics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ACCUVEIN plus ultrasound

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Ultrasound only

Intervention Type: DEVICE

Intervention is marking with ultrasound imaging as in usual practice.

Interventions

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

Intervention Type: DEVICE

Ultrasound only

Intervention is marking with ultrasound imaging as in usual practice.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HENNI MD SAMIR, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

UH Angers

Angers, , France

Countries

France

Other Identifiers

2018-A01101-54

Identifier Type: -

Identifier Source: org_study_id