"Clinical Ultrasound, a New Link Between Town and Hospital in Seine-Saint-Denis". (ECHO93)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The ECHO93 study is a non-healthcare interventional study. Its aim is to evaluate the effect of introducing the echOpen probe into the management of patients referred to the Jean Verdier UDR, in terms of time to diagnosis.
The study is divided into 3 phases:
Phase 1: opening of the Rapid Diagnosis Unit (UDR) at Jean Verdier Hospital Phase 2: Opening of the Jean Verdier Hospital UDR, MSP Pantin, Dr TAYBALY's medical practice in Aulnay-sous-Bois, one month after the start of phase 1.
Phase 3: Opening of the Jean Verdier Hospital Health Bus, one month after the start of phase 2.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient over 18 years of age
Patient with signed informed consent
one of the structures involved (UDR/ SAU Jean Verdier, MSP Pantin, Cabinet Médical du Dr TAYBALY à Aulnay-sous-Bois) for referral to the UDR for rapid diagnosis (phases 1 and 2)
the Health Bus (phase 3)
Disqualifiers
Patient on the UDR iron-deficiency anemia clinical pathway
Patient deprived of liberty by judicial or administrative decision
Patient who does not speak French and cannot benefit from the presence of a relative or translator (physical or online)
patients with a body mass index greater than 34.9 kg/m2
Trial design
Design model
Single group
Treatments tested in this trial
Echoscopy examination using the echOpen probe
DeviceIn addition to standard care, each patient will have a systematic 4-point echoscopy examination using the echOpen probe: liver, spleen, lymph nodes, thyroid and, depending on symptoms, lung, kidney, bladder, abdomen. The echOpen probe is CE marked. It will be used for all indications except certain areas of the body (thyroid, lymph nodes, bladder, liver, spleen, kidney, bladder and lymph nodes). In addition to echoscopy with the echOpen probe, patient and physician satisfaction questionnaires will be used as part of this study.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: echoscopy examination using the echOpen probeOther 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the effect of introducing the echOpen probe into the management of patients referred to the Jean Verdier Rapid Diagnostic Unit (UDR) on time to diagnosis.
The time between the first contact with the Rapid Diagnosis Unit (RDU) and the date of the diagnosis (date of discharge from the RDU) in patients who had an ultrasound scan with the echOpen probe in consultation at the RDU (phase 1) and in patients who had it in consultation with a general practitioner or in the emergency department (phase 2), compared with the time before the echOpen was introduced.
Time frame
Visite discharge from the RDU ( Maximum 2 months after inclusion visit)Secondary outcomes
1
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.
\- The number of complementary examinations prescribed/avoided, in comparison with the number of examinations prior to the introduction of the echOpen.
Time frame
Visite discharge from the RDU ( Maximum 2 months after inclusion visit)2
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.
\- The time between the first consultation and the radioguided biopsy, if this is to be carried out
Time frame
Visite discharge from the RDU ( Maximum 2 months after inclusion visit)3
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.
\- The number of patients accessing the UDR day hospital directly will be evaluated in patients having had an echoscopy with the echOpen probe in consultation at the UDR (phase 1) in comparison with the number of patients before the introduction of the echOpen.
Time frame
Visite discharge from the RDU ( Maximum 2 months after inclusion visit)4
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.
\- The number of patients referred to the emergency department facilitated by the echOpen probe will be evaluated among patients who had an echOpen probe in the Health Bus (phase 3), compared with the number of patients before the echOpen was introduced.
Time frame
Visite discharge from the RDU ( Maximum 2 months after inclusion visit)Sponsors and contacts
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Source ClinicalTrials.gov