Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier
Bondy, France
Location status: Recruiting
NCT Number: NCT06774924
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bondy, France
Location status: Recruiting
This research will be carried out in 3 phases:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In 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.
Other names: patient and investigator satisfaction questionnaires
Time frame: Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
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)
Time frame: Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
Time frame: Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
Time frame: Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
Time frame: Through study completion, an average of 2 years for phase 1 and 2, at each inclusion visit of patient (day 1) for phase 3
Physician satisfaction (phases 1 and 2) will be assessed by a questionnaire carried out at the end of the study. For Health Bus doctors (phase 3), the questionnaire will be completed after each patient consultation. A visual analog scale will be proposed in this questionnaire to assess doctors' overall satisfaction with the use of EchOpen. This scale ranges from 0 (very dissatisfied) to 10 (very satisfied).
Time frame: once a week throughout the entire inclusion period which is 16 months
Physicians' satisfaction will also be assessed by a weekly questionnaire sent directly to them by the EchOpen team.
Time frame: Visit discharge from the RDU ( Maximum 2 months after inclusion visit) for pahse 1 and 2. At the Inclusion visit (day 1) for phase 3
Patient satisfaction (phases 1 and 2) will be assessed by a questionnaire administered on discharge from the UDR. For Health Bus patients (phase 3), the questionnaire will be carried out at the Inclusion/Final visit. This questionnaire will include a visual analog scale to assess patients' overall satisfaction with the EchOpen. The scale ranges from 0 (very dissatisfied) to 10 (very satisfied).
Contact information is provided by the study sponsor or research team.
Anne BOURGARIT, PUPH
CONTACT
Fadhila MESSANI
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Acronym: ECHO93
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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