Status:

COMPLETED

Efficacy of the echOpen Device to Identify Effusion and to Detect Basilic Vein

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

ECHOPEN

EIT Health

Conditions:

Pleural Effusion

Abdominal Effusion

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize...

Detailed Description

The echOpen device includes an ultrasound probe and a mobile application. The mechanical probe emits at three ultrasound frequencies, 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, which allows the exploration of the ...

Eligibility Criteria

Inclusion

  • Adult patient (age ≥ 18 years old)
  • Patient having signed the informed consent to participate in this clinical investigation
  • Patient affiliated to the social security scheme
  • Patient arriving in the hospital clinical ward (own initiative or by emergency services) whose clinical symptomatology (e.g. dyspnea, thoracic pain, etc.) suggests the presence of pathological elements (effusion) which would be visible using an ultrasound probe
  • Patient consulting in the hospital clinical ward who could potentially benefit from a basilic vein line placement using an ultrasound device

Exclusion

  • Minor patient (age \< 18 years)
  • Patients under the "State medical assistance"
  • Obese patient (body mass index \> 29.9)
  • Patient in too serious condition for the clinical examination to be done fully and/or with additional exploratory time
  • Unstable patient: need for immediate care, impossibility to carry out a thorough clinical examination including interview, palpation, auscultation, percussion
  • Known allergy to ultrasound gel

Key Trial Info

Start Date :

April 4 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 19 2022

Estimated Enrollment :

201 Patients enrolled

Trial Details

Trial ID

NCT05280119

Start Date

April 4 2022

End Date

August 19 2022

Last Update

December 8 2022

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Avicenne Hospital - APHP - Hepatology Department

Bobigny, France, 93140

2

Cochin Hospital - APHP - Emergency Department

Paris, France, 75014

3

Cochin Hospital - APHP - Pneumology department

Paris, France, 75014

4

Paul Brousse Hospital - APHP - Hepatobiliary Center

Villejuif, France, 94800