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Robot-Based Tele-Echography II - A Comparative Study
This study has been terminated.
( No diagnosis of visceral lesion was placed on 18 included patients. The study is thus stopped prematurely for ethical reasons. )
First Received: February 21, 2006   Last Updated: April 6, 2009   History of Changes
Sponsor: University Hospital, Grenoble
Collaborator: France Telecom R&D
Information provided by: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00295438
  Purpose

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.


Condition Intervention
Abdominal Injuries
Thoracic Injuries
High Energy Trauma
 Device: Robot-Based Tele-Echography : the TER system

Study Type: Interventional
Study Design: Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy 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.

Resource links provided by NLM:

MedlinePlus related topics: Injuries Ultrasound Wounds
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • sensitivity, specificity, PPV, NPV are estimated with a 95% confidence interval
  • qualitative scores (including comfort and experience of the patient, quality of the echographic method evaluated by the physicians).

Enrollment: 18
Study Start Date: February 2006
Study Completion Date: March 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Robot-Based Tele-Echography : the TER system
    Robot-Based Tele-Echography
Detailed Description:
  1. 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).
  2. 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.
  3. Objective 3: qualitative evaluation of each echographic method by the patient and the physicians.
  4. 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Person registered with the French Social Security or benefiting from an equivalent health insurance system
  • Person sent to hospital for thoracoabdominal high energy trauma

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295438

Locations
France
University Hospital
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
France Telecom R&D
Investigators
Principal Investigator: Jean-Jacques Banihachemi, MD Urgences Traumatologiques de l'hôpital SUD - Centre Hospitalier et Universitaire - Grenoble - B.P. 185 38042 GRENOBLE Cedex 09 - France
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:
Vilchis A, Masuda K, Troccaz J, Cinquin P. Robot-based tele-echography: the TER system. Stud Health Technol Inform. 2003;95:212-7.

Responsible Party: University Hospital of Grenoble ( Jean-Jacques Banihachemi )
Study ID Numbers: DCIC 05 52
Study First Received: February 21, 2006
Last Updated: April 6, 2009
ClinicalTrials.gov Identifier: NCT00295438     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:
robot-based tele-echography
tele-medicine

Additional relevant MeSH terms:
Thoracic Injuries
Wounds and Injuries
Disorders of Environmental Origin
Abdominal Injuries

ClinicalTrials.gov processed this record on November 05, 2009



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