Deep Vein ThrombosisEchoComp TVPNCT02262494
Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography
A study testing portable venous compression ultrasonography, venous compress ultrasonography and Doppler ultrasound of the lower limbs in people with Deep Vein Thrombosis, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis
- What is being tested?
- portable venous compression ultrasonography, venous compress ultrasonography and Doppler ultrasound of the lower limbs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2015to 19 Oct 2016
- 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
- The patient must have given informed consent and signed consent
- The patient must be a member or beneficiary of a health insurance plan
- Patient consulting in the vascular exploration and medicine department for suspected first episode of deep vein thrombosis
- Ambulatory patient: defined as any outpatient coming in for a consult directly from their place of residence or via the emergency department
- Patient does not have a history of venous thromboembolism
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is an adult under any kind of guardianship
- The patient refuses to sign the consent
- It is not possible to correctly inform the patient
- Patient has a history of venous thromboembolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study
The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.
Read the detailed description
The secondary objectives of this study are:
- to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (V-Scan®) with that of emergency compression ultrasonography performed with a classic device
- to compare the diagnostic performance of emergency compression ultrasonography between patients suspected of having DVT arriving through the emergency department versus similar patients sent in by their generalist
- to compare the diagnostic performance of emergency compression ultrasonography among patients with suspected DVT according to pre clinical probability testing based on the Wells score (low, medium or high probability).
Currently, the use of ultra-portable ultrasound in this indication is not part of routine care, and this study is therefore considered interventional in nature.
- Conditions
- Deep Vein Thrombosis
- Being tested
- portable venous compression ultrasonography, venous compress ultrasonography, Doppler ultrasound of the lower limbs
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable venous compression ultrasonographyProcedure or surgery
venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
venous compress ultrasonographyProcedure or surgery
venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
Doppler ultrasound of the lower limbsProcedure or surgery
Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)
| Study group | Role | What they receive |
|---|---|---|
| Suspected first episode of DVT | Other | The study population consists of patients presenting with suspected first episode of DVT at the Nîmes University Hospital.
Intervention: portable venous compression ultrasonography Intervention: venous compress ultrasonography Intervention: Doppler ultrasound of the lower limbs Receives: Procedure: portable venous compression ultrasonography; Procedure: venous compress ultrasonography; Procedure: Doppler ultrasound of the lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of deep vein thrombosis by portable ultrasound: yes/no
Measured: Day 0
Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no
Measured: Day 0
Secondary outcomes (2)
Diagnosis of deep vein thrombosis by classic ultrasound: yes/no
Measured: day 0
Wells score
score ranging from 0 to 6
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study start10 Apr 2015
- Primary completion19 Oct 2016
- Study completion19 Oct 2016
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Bobbia, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262494
- Sponsor's protocol ID
- LOCAL/2013/XB-01
- Other IDs
- 2014-A00510-47
- Acronym
- EchoComp TVP
- Status last verified
- Jan 2018
- First submitted
- 2 Oct 2014
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study
- ClinicalTrials.gov ID
- NCT02262494
- Acronym / sponsor ID
- EchoComp TVP / LOCAL/2013/XB-01
- Conditions
- Deep Vein Thrombosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No recruitment
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 10 Apr 2015 (actual)
- Primary completion
- 19 Oct 2016 (actual)
- Study completion
- 19 Oct 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- 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.
The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.
Detailed description
The secondary objectives of this study are:
- to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (V-Scan®) with that of emergency compression ultrasonography performed with a classic device
- to compare the diagnostic performance of emergency compression ultrasonography between patients suspected of having DVT arriving through the emergency department versus similar patients sent in by their generalist
- to compare the diagnostic performance of emergency compression ultrasonography among patients with suspected DVT according to pre clinical probability testing based on the Wells score (low, medium or high probability).
Currently, the use of ultra-portable ultrasound in this indication is not part of routine care, and this study is therefore considered interventional in nature.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected first episode of DVT | Other | Procedure: portable venous compression ultrasonography, Procedure: venous compress ultrasonography, Procedure: Doppler ultrasound of the lower limbsThe study population consists of patients presenting with suspected first episode of DVT at the Nîmes University Hospital. Intervention: portable venous compression ultrasonography Intervention: venous compress ultrasonography Intervention: Doppler ultrasound of the lower limbs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must have given informed consent and signed consent
- The patient must be a member or beneficiary of a health insurance plan
- Patient consulting in the vascular exploration and medicine department for suspected first episode of deep vein thrombosis
- Ambulatory patient: defined as any outpatient coming in for a consult directly from their place of residence or via the emergency department
- Patient does not have a history of venous thromboembolism
Key exclusion criteria (6 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is an adult under any kind of guardianship
- The patient refuses to sign the consent
- It is not possible to correctly inform the patient
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 |
|---|---|---|
| portable venous compression ultrasonographyvenous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician) | Procedure or surgery | Suspected first episode of DVT |
| venous compress ultrasonographyvenous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist) | Procedure or surgery | Suspected first episode of DVT |
| Doppler ultrasound of the lower limbsDoppler ultrasound of the lower limbs (gold standard; by exploratory specialist) | Procedure or surgery | Suspected first episode of DVT |
Primary outcome
Diagnosis of deep vein thrombosis by portable ultrasound: yes/no
Time frame: Day 0
Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no
Time frame: Day 0
2 secondary outcomes
Diagnosis of deep vein thrombosis by classic ultrasound: yes/no
Time frame: day 0
Wells score
Time frame: Day 0
Results and safety
The study was stopped early (reason given: No recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
Xavier Bobbia, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing portable venous compression ultrasonography, venous compress ultrasonography and Doppler ultrasound of the lower limbs in people with Deep Vein Thrombosis, run by Centre Hospitalier Universitaire de Nīmes 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 3 Jan 2018. 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. 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 was stopped early (reason given: No recruitment). Results are not available in the source record.
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?
Diagnosis of deep vein thrombosis by portable ultrasound: yes/no (time frame: Day 0). The study lists 2 primary outcomes in all. 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 3 Jan 2018.