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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02262494
Other study ID # LOCAL/2013/XB-01
Secondary ID 2014-A00510-47
Status Terminated
Phase N/A
First received October 2, 2014
Last updated January 2, 2018
Start date April 10, 2015
Est. completion date October 19, 2016

Study information

Verified date January 2018
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.


Description:

The secondary objectives of this study are:

- to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (V-ScanĀ®) 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.


Recruitment information / eligibility

Status Terminated
Enrollment 56
Est. completion date October 19, 2016
Est. primary completion date October 19, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

Procedure:
portable venous compression ultrasonography
venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
venous compress ultrasonography
venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
Doppler ultrasound of the lower limbs
Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)

Locations

Country Name City State
France CHRU de Nîmes - Hôpital Universitaire Carémeau Nîmes Cedex 9

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosis of deep vein thrombosis by portable ultrasound: yes/no Day 0
Primary Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no Day 0
Secondary Diagnosis of deep vein thrombosis by classic ultrasound: yes/no day 0
Secondary Wells score score ranging from 0 to 6 Day 0
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