CClinicalTrials.gg
TerminatedNCT03555006TELECHOUpdated Oct 7, 2022

Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist

An interventional study of Dual ultrasound reading "local vs remote" and Dual ultrasound reading "local vs local" in Tele-ultrasound, sponsored by Centre Hospitalier Régional Metz-Thionville. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Centre Hospitalier Régional Metz-Thionville · Not applicable, Interventional, and Diagnostic

Why this study was terminated
because of the health crisis, organizational constraints and the lack of medical and paramedical staff
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study tries to evaluate the non-inferiority quality and safety of ultrasound examinations realise by electro-radiology assistant with a remote radiologist compared to those realize by electro-radiology assistant with a referent radiologist on site.

Read the detailed description

The number of requests for medical imaging examinations is clearly growing while there is an understaffing among the radiologists. The solution is the amelioration of information transmission technologies, for organize a territorial teleradiology in order to care duty. Currently, in the ultrasound field, the investigators can't realize image transfer because analyse and expertise are made during examination and only reading of fixed images can't be enough for the examination interpretation.

The most part of other developed countries recognize a paramedical job devoted to ultrasound. Tele-ultrasound is used in expert resort, for example during high-risk pregnancy.

A French society commercializes tele-ultrasound robots, arranged by a caregiver beside sick person and a tele-radiologist realize acquisition of information and images with remote commands from robot.

The CHR Metz-Thionville has a cooperation protocol between electro-radiology assistants and radiologists for the ultrasound practical, endorsed by Lorraine ARS and HAS (French health organizations) since 2012, and currently national impact.

This study purpose to evaluation the non-inferiority of agreement between two interpretations of the same ultrasound realize by an electro-radiology assistant on the one hand by two radiologists present in the radiology service and on the other hand, one radiologist in by the radiology service and one remote radiologist.

02

Conditions studied

  • Tele-ultrasound
03

In context

Lead sponsor

Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 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

Inclusion criteria

  • Major patient
  • Who needs abdomino-pelvic ultrasound, except emergency cases
  • With no substitutable examination

Exclusion criteria

Exclusion Criteria:

  • Pregnant and nursing women
  • Patient in the incapacity to express his consent
  • Unavailability of a remote radiologist or a second local radiologist during the examination realization
  • Patient opposed to use data
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Other
    Local vs remote group

    The examination will be interpreted by a department's radiologist and by a remote radiologist in blind of the first interpretation

    Other: Dual ultrasound reading "local vs remote"

  • Other
    Local vs local group

    The examination will be interpreted by two department's radiologists

    Other: Dual ultrasound reading "local vs local"

Interventions

  • OtherDual ultrasound reading "local vs remote"

    The examination will be interpreted by a department's radiologist and by a remote radiologist in blind of the first interpretation and a posteriori by a third radiologist.

  • OtherDual ultrasound reading "local vs local"

    The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist.

06

What researchers measure

Primary outcomes

  1. Percentage of consistency between the reports

    It will be evaluated in blind by a third radiologist with the RADPEER scoring.

    Time frame: Day 1

07

Study locations

1 site
  • CHR Metz Thionville
    Metz, 57085, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03555006
Lead sponsor
Centre Hospitalier Régional Metz-Thionville
Responsible party
Sponsor
First posted
Jun 13, 2018
Start date
Oct 16, 2018
Primary completion
Mar 13, 2020
Completion
Mar 13, 2020
Last update
Oct 7, 2022

Study contacts

Elisabeth PARIZEL, MD
principal investigator · CHR Metz Thionville

Oversight

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

Not currently enrolling

This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion