Other Diseases of Veins and LymphaticsACCUMULATIONNCT03538080
ACCUvein Measure Before ULtrasound as A facilitataTION Tool for Venous Marking
A study testing ACCUVEIN plus ultrasound and Ultrasound only in people with Other Diseases of Veins and Lymphatics, run by University Hospital, Angers at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Diseases of Veins and Lymphatics
- What is being tested?
- ACCUVEIN plus ultrasound and Ultrasound only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2018to 20 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for venous marking
- Affiliation to the French National healthcare system
- French speaking patients
Who cannot join
- pregnancy
- inability to understand the study goal
- patients protected by decision of law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- ACCUVEIN plus ultrasound, Ultrasound only
- Keywords
- venous disease, peripheral vascular disease, vascular surgery, ultrasound imaging
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACCUVEIN plus ultrasoundDevice
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 onlyDevice
Intervention is marking with ultrasound imaging as in usual practice.
| Study group | Role | What they receive |
|---|---|---|
| ACCUVEIN plus ultrasound | Experimental | 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 Receives: Device: ACCUVEIN plus ultrasound |
| Ultrasound only | Sham comparator | 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. Receives: Device: Ultrasound only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: inclusion
Secondary outcomes (2)
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
Measured: 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
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start3 Sep 2018
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Diseases of Veins and LymphaticsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- HENNI MD SAMIR, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538080
- Sponsor's protocol ID
- 2018-A01101-54
- Acronym
- ACCUMULATION
- Status last verified
- Aug 2020
- First submitted
- 18 Jan 2018
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation du pré-marquage Par AccuVein® au Cours Des échographies Doppler de repérage saphène.
- ClinicalTrials.gov ID
- NCT03538080
- Acronym / sponsor ID
- ACCUMULATION / 2018-A01101-54
- Conditions
- Other Diseases of Veins and Lymphatics
- Keywords
- venous disease, peripheral vascular disease, vascular surgery, ultrasound imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACCUVEIN plus ultrasound | Experimental | Device: ACCUVEIN plus ultrasoundPatients 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 |
| Ultrasound only | Sham comparator | Device: Ultrasound onlyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for venous marking
- Affiliation to the French National healthcare system
- French speaking patients
Key exclusion criteria (3 listed)
- pregnancy
- inability to understand the study goal
- patients protected by decision of law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACCUVEIN plus ultrasoundIntervention 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 | Device | ACCUVEIN plus ultrasound |
| Ultrasound onlyIntervention is marking with ultrasound imaging as in usual practice. | Device | Ultrasound only |
Primary outcome
Time to perform the saphenous vein marking with AccuVein® system
Time frame: inclusion
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.
2 secondary outcomes
Degree of satisfaction of the vascular physician and the surgeon
Time frame: inclusion
Rate of consumables
Time frame: inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HENNI MD SAMIR, PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACCUVEIN plus ultrasound and Ultrasound only in people with Other Diseases of Veins and Lymphatics, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to perform the saphenous vein marking with AccuVein® system (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.