Abdominal InjuriesNCT00295438
Robot-based Tele-echography II - A Comparative Study
A study testing Robot-Based Tele-Echography (TER) and ultrasound method FAST in people with Abdominal Injuries and Thoracic Injuries, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based tele-echography performed by radiologists in a remote location. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Injuries, Thoracic Injuries, High Energy Trauma
- What is being tested?
- Robot-Based Tele-Echography (TER) and ultrasound method FAST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to Mar 2009
- 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
- Person registered with the French Social Security or benefiting from an equivalent health insurance system
- Person sent to hospital for thoracoabdominal high energy trauma
Who cannot join
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
- Person participating in another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robot-based Tele-echography II - A Comparative Study Using Two Echographic Modalities for Diagnosis of Thoracoabdominal Injuries at the Trauma Center of the Grenoble University Hospital.
The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based tele-echography performed by radiologists in a remote location. The second is bedside echography performed by emergency physicians according to the FAST (Focussed Assessment by Sonography of Trauma) examination.
Read the detailed description
- Principal objective: to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods (robot-based tele-echography performed by radiologists in a remote location vs bedside echography performed by emergency physicians according to the FAST examination).
- Objective 2: after the realization of a gold standard method, if there is a concordance between the two different echographic methods, sensitivity and specificity are estimated. If not, the evaluation of sensitivity and specificity of each method with analysis of their discordance is performed.
- Objective 3: qualitative evaluation of each echographic method by the patient and the physicians.
- Material and methods: This therapeutic, mono-centre, prospective, randomized, cross-over, open, controlled trial is being conducted in 70 patients. All the patients will have the two different echographic methods in a sequential but randomized way. The robot-based tele-echography is performed by a radiologist in the North University Hospital of Grenoble. The bedside echography is performed by the emergency physicians in the trauma center in the South University Hospital of Grenoble.
- Conditions
- Abdominal Injuries, Thoracic Injuries, High Energy Trauma
- Being tested
- Robot-Based Tele-Echography (TER), ultrasound method FAST
- Keywords
- robot-based tele-echography, tele-medicine
- Medical subject headings
- Abdominal Injuries, Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Based Tele-Echography (TER)Device
Robot-Based Tele-Echography, ultrasound performed by the radiologist
ultrasound method FASTDevice
FAST,ultrasound performed by the emergency doctor
| Study group | Role | What they receive |
|---|---|---|
| Robot-Based Tele-Echography (TER) | Experimental | ultrasound performed according to the method Tele-Echography Receives: Device: Robot-Based Tele-Echography (TER); Device: ultrasound method FAST |
| ultrasound method FAST | Active comparator | ultrasound performed according to the method FAST (Focused Assessment Sonography for Trauma) Receives: Device: Robot-Based Tele-Echography (TER); Device: ultrasound method FAST |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnosis concordance between the radiologists using the robot-based tele-echography and the emergency physicians (FAST bedside examination) is evaluated thanks to the Cohen kappa interrater agreement coefficient.
Measured: 6 month
Secondary outcomes (2)
sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval
Measured: 6 month
qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2009
- Study completionMar 2009
Why it stopped: No diagnosis of visceral lesion was placed on 18 included patients. The study is thus stopped prematurely for ethical reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal InjuriesStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- France Telecom R&D
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Banihachemi, MD, Principal investigator, Urgences Traumatologiques de l'hôpital SUD - Centre Hospitalier et Universitaire - Grenoble - B.P. 185 38042 GRENOBLE Cedex 09 - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295438
- Sponsor's protocol ID
- DCIC 05 52
- Status last verified
- Sep 2016
- First submitted
- 21 Feb 2006
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7.
PubMed 14663989
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-based Tele-echography II - A Comparative Study Using Two Echographic Modalities for Diagnosis of Thoracoabdominal Injuries at the Trauma Center of the Grenoble University Hospital.
- ClinicalTrials.gov ID
- NCT00295438
- Acronym / sponsor ID
- DCIC 05 52
- Conditions
- Abdominal Injuries, Thoracic Injuries, High Energy Trauma
- Keywords
- robot-based tele-echography, tele-medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No diagnosis of visceral lesion was placed on 18 included patients. The study is thus stopped prematurely for ethical reasons.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- France Telecom R&D
- Study start
- Feb 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 23 Feb 2006 (estimated)
- 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.
The aim of this clinical trial is to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods. The first method is a robot-based tele-echography performed by radiologists in a remote location. The second is bedside echography performed by emergency physicians according to the FAST (Focussed Assessment by Sonography of Trauma) examination.
Detailed description
- Principal objective: to evaluate the concordance of diagnosis of injuries in thoracoabdominal trauma using two different echographic methods (robot-based tele-echography performed by radiologists in a remote location vs bedside echography performed by emergency physicians according to the FAST examination).
- Objective 2: after the realization of a gold standard method, if there is a concordance between the two different echographic methods, sensitivity and specificity are estimated. If not, the evaluation of sensitivity and specificity of each method with analysis of their discordance is performed.
- Objective 3: qualitative evaluation of each echographic method by the patient and the physicians.
- Material and methods: This therapeutic, mono-centre, prospective, randomized, cross-over, open, controlled trial is being conducted in 70 patients. All the patients will have the two different echographic methods in a sequential but randomized way. The robot-based tele-echography is performed by a radiologist in the North University Hospital of Grenoble. The bedside echography is performed by the emergency physicians in the trauma center in the South University Hospital of Grenoble.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Based Tele-Echography (TER) | Experimental | Device: Robot-Based Tele-Echography (TER), Device: ultrasound method FASTultrasound performed according to the method Tele-Echography |
| ultrasound method FAST | Active comparator | Device: Robot-Based Tele-Echography (TER), Device: ultrasound method FASTultrasound performed according to the method FAST (Focused Assessment Sonography for Trauma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Person registered with the French Social Security or benefiting from an equivalent health insurance system
- Person sent to hospital for thoracoabdominal high energy trauma
Key exclusion criteria (6 listed)
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
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 |
|---|---|---|
| Robot-Based Tele-Echography (TER)Robot-Based Tele-Echography, ultrasound performed by the radiologist | Device | Robot-Based Tele-Echography (TER), ultrasound method FAST |
| ultrasound method FASTFAST,ultrasound performed by the emergency doctor | Device | Robot-Based Tele-Echography (TER), ultrasound method FAST |
Primary outcome
The diagnosis concordance between the radiologists using the robot-based tele-echography and the emergency physicians (FAST bedside examination) is evaluated thanks to the Cohen kappa interrater agreement coefficient.
Time frame: 6 month
2 secondary outcomes
sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval
Time frame: 6 month
qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).
Time frame: 6 month
Results and safety
The study was stopped early (reason given: No diagnosis of visceral lesion was placed on 18 included patients. The study is thus stopped prematurely for ethical reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Background: PubMed 14663989Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7.
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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.
Jean-Jacques Banihachemi, MD principal investigator
Urgences Traumatologiques de l'hôpital SUD - Centre Hospitalier et Universitaire - Grenoble - B.P. 185 38042 GRENOBLE Cedex 09 - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Based Tele-Echography (TER) and ultrasound method FAST in people with Abdominal Injuries and Thoracic Injuries, run by University Hospital, Grenoble 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 2 inclusion and 6 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 15 Sep 2016. 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: No diagnosis of visceral lesion was placed on 18 included patients. The study is thus stopped prematurely for ethical reasons.). 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?
The diagnosis concordance between the radiologists using the robot-based tele-echography and the emergency physicians (FAST bedside examination) is evaluated thanks to the Cohen kappa interrater agreement coefficient. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00295438, which also lists 1 linked publication.
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 15 Sep 2016.