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CompletedNCT04127149EPEMedGUpdated Dec 19, 2025

Evaluation of Ultra-portable Ultrasound in General Practice

An interventional study of Ultrasound scan in Pneumonia, Pleural Effusion and Renal Colic, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
166
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an interventional multi-centre study comparing two groups of general practitioners with or without an ultrasound scanner over a period of 6 months. The evaluation focuses on the management of patients for 8 pathologies:

  • Pneumonia
  • Pleural effusion
  • Renal colic
  • Hepatic colic or cholecystitis
  • Subcutaneous abscess or cyst
  • Fracture of long bones
  • Intra-uterine pregnancy or extra-uterine pregnancy or miscarriage
  • Phlebitis The principal hypothesis is that there are fewer complementary exams in the group of doctors using ultrasound scanners.

The secondary hypotheses are:

  • There is better patient orientation (emergency care, specialist consultation, return home) in the group of doctors using the ultrasound scanners.
  • The global cost of the care is lower in the group of doctors using the ultrasound.
  • Using ultrasound during the consultation decreases the anxiety of the patient.
  • Using ultrasound increases the duration of the consultation.
  • There is no difference between the predicted and the real orientation of the patients.
02

Conditions studied

  • Pneumonia
  • Pleural Effusion
  • Renal Colic
  • Hepatic Colic or Cholecystitis
  • Subcutaneous Abscess or Cyst
  • Fracture of Long Bones
  • Intra-uterine Pregnancy or Extra-uterine Pregnancy or Miscarriage
  • Phlebitis

Keywords

  • ultrasound scanner
  • sonogram
  • general practice
03

In context

Pneumonia

1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.

This study's enrollment of 166 is above the median of 129 across 975 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients age 18 and over
  • consulting their general practitioner for one of the 8 conditions below

Exclusion criteria

Exclusion Criteria:

  • patients who have already received an imagery exam for the acute episode justifying the consult
  • opposition to participate
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
166 participants (actual)

Study arms

  • Experimental
    Group with ultrasound

    The first group consists of nine general practitioners having received a brief training on the use of ultrasound scanners in general practice. The general practitioner includes all adult patients who are consulting for one of the 8 medical conditions studied and perform an ultrasound scan. Two weeks later, he/she calls each patient to collect the necessary data.

    Diagnostic Test: Ultrasound scan

  • No intervention
    Group without ultrasound

    The second group consists of nine general practitioners. Each physician includes all adult patients who are consulting for one of the 8 medical conditions studied and performs a standard consultation. Two weeks later, he/she calls each patient to collect the necessary data.

Interventions

  • Diagnostic testUltrasound scan

    The group uses an ultrasound device for the consultation.

06

What researchers measure

Primary outcomes

  1. Number of complementary exams

    Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know: * The number of imagery exams they had (ultrasound, MRI, scanner, radiology…) * The number of biological analysis (CRP, ASAT, ALAT, Lipase…)

    Time frame: Two weeks after inclusion

Secondary outcomes

  1. Number of hospitalisations, specialist orientation or return home

    Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know if within the past two weeks, they have been hospitalised, required emergency care, needed to consult a specialist, or returned back home

    Time frame: Two weeks after inclusion

  2. Cost of care

    After knowing the patient orientation and the complementary exams they had, an estimation of the cost of care is made.

    Time frame: Four weeks after inclusion in the study

  3. Anxiety score measured by the State-Trait Anxiety Inventory (STAI-Y) scale

    Two weeks after the initial consultation, with or without ultrasound scanners, the general practitioners call their patients to know the result of the anxiety test they took the day of the first consultation.

    Time frame: Two weeks after inclusion in the study

  4. Consultation duration

    The day of the first consultation, the general practitioner writes the time spent

    Time frame: Two weeks after inclusion in the study

07

Study locations

1 site
  • Maison de santé pluridisciplinaire Léopold Ollier
    Les Vans, 07140, France
08

References and documents

Publications

  • Dasse-Hartaut J, Couture S. Pragmatic evaluation of handheld point-of-care ultrasound in general practice. MD thesis. Claude Bernard University Lyon 1; 2021. Thesis supervisor: Dr Francis Pellet.
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2019 to primary completion in Oct 2021, 22 months.

Of 258 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's 22 months is close to that.

Counting every sponsor, half of 265 studies reached it within 21 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2019
First posted
Oct 15, 2019
StartActual
Dec 3, 2019
Primary completionActual
Oct 20, 2021
CompletionActual
Oct 20, 2021
Last update
Dec 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04127149
Responsible party
Sponsor
First posted
Oct 15, 2019
Start date
Dec 3, 2019
Primary completion
Oct 20, 2021
Completion
Oct 20, 2021
Last update
Dec 19, 2025

Study contacts

Francis PELLET, MD
principal investigator · Maison de sante pluridisciplinaire Leopold Ollier Les Vans

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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