Tele-ultrasoundTELECHONCT03555006
Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist
A study testing Dual ultrasound reading "local vs remote" and Dual ultrasound reading "local vs local" in people with Tele-ultrasound, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tele-ultrasound
- What is being tested?
- Dual ultrasound reading "local vs remote" and Dual ultrasound reading "local vs local"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient
- Who needs abdomino-pelvic ultrasound, except emergency cases
- With no substitutable examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist for the Realization of Some Exploration Indications by Ultrasound
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.
- Conditions
- Tele-ultrasound
- Being tested
- Dual ultrasound reading "local vs remote", Dual ultrasound reading "local vs local"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual ultrasound reading "local vs remote"Other
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.
Dual ultrasound reading "local vs local"Other
The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist.
| Study group | Role | What they receive |
|---|---|---|
| Local vs remote group | Other | The examination will be interpreted by a department's radiologist and by a remote radiologist in blind of the first interpretation Receives: Other: Dual ultrasound reading "local vs remote" |
| Local vs local group | Other | The examination will be interpreted by two department's radiologists Receives: Other: Dual ultrasound reading "local vs local" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of consistency between the reports
It will be evaluated in blind by a third radiologist with the RADPEER scoring.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start16 Oct 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: because of the health crisis, organizational constraints and the lack of medical and paramedical staff
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tele-ultrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth PARIZEL, MD, Principal investigator, CHR Metz Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555006
- Sponsor's protocol ID
- 2016-04-CHRMT
- Acronym
- TELECHO
- Status last verified
- Oct 2022
- First submitted
- 1 Jun 2018
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist for the Realization of Some Exploration Indications by Ultrasound
- ClinicalTrials.gov ID
- NCT03555006
- Acronym / sponsor ID
- TELECHO / 2016-04-CHRMT
- Conditions
- Tele-ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because of the health crisis, organizational constraints and the lack of medical and paramedical staff
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local vs remote group | Other | Other: Dual 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 |
| Local vs local group | Other | Other: Dual ultrasound reading "local vs local"The examination will be interpreted by two department's radiologists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major patient
- Who needs abdomino-pelvic ultrasound, except emergency cases
- With no substitutable examination
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual 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. | Other | Local vs remote group |
| Dual ultrasound reading "local vs local"The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist. | Other | Local vs local group |
Primary outcome
Percentage of consistency between the reports
Time frame: Day 1
It will be evaluated in blind by a third radiologist with the RADPEER scoring.
Results and safety
The study was stopped early (reason given: because of the health crisis, organizational constraints and the lack of medical and paramedical staff). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth PARIZEL, MD principal investigator
CHR Metz Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual ultrasound reading "local vs remote" and Dual ultrasound reading "local vs local" in people with Tele-ultrasound, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: because of the health crisis, organizational constraints and the lack of medical and paramedical staff). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of consistency between the reports (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.