Trial document




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  DRKS00017112

Trial Description

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Title

Prospective evaluation of screen-based interventions with a standalone system

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Trial Acronym

Orbeye study

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The current evolution of exoscopic surgery marks a paradigm shift in neurosurgery and comes with multiple new systems ready for market introduction. Hence, it is vital to analyze the impact of the technology on neurosurgical practice. Multiprofessional scientific effort is needed to accompany the intraoperative application and further development of the systems.

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Brief Summary in Scientific Language

Coming with a broad range of novel digital visualization options, videoscopes are a promising alternative to established surgical microscopes. Standalone exoscopes, in particular, offer different advantages and disadvantages in surgical routine than hybrid technologies. This study examines the utilization and image quality of the Olympus Orbeye in neurosurgical routine interventions in head and spine. The goal is to define the most eligible procedures and intraoperative setups as well as to analyze the image quality in detail. Thereby, the study will contribute to more general insights into requirements of neurosurgical visualization. Patients with cranial and spinal pathologies will be selected by the surgeon for screen-based interventions. A switch to conventional ocular-based surgery is possible at any time.

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Organizational Data

  •   DRKS00017112
  •   2019/05/02
  •   [---]*
  •   yes
  •   Approved
  •   EA1/048/19, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C71 -  Malignant neoplasm of brain
  •   M51 -  Other intervertebral disc disorders
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Interventions/Observational Groups

  •   Surgery with videoscope
  •   Surgery with conventional surgical microscope
  •   Surgery with hybrid exoscope
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

- definition of most relevant application areas (type of intervention, duration of surgery, surgical access, number of surgeon users per intervention, additional equipment, intraoperative setup) of the videoscope in neurosurgery - documentation and user survey during and after each surgery

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Secondary Outcome

- analysis of image quality in relation to the surgical intervention
- definition of best practice-scenarios

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/05/08
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Cranial or spinal pathologies suitable for microsurgery
- age > 18 years
- cases suitable for both microscope and exoscope/videoscope
- surgeons trained in both modalities

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Exclusion Criteria

Multimorbidity

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Neurochirurgie, Charité-Universitätsmedizin Berlin
    • Mr.  PD Dr. med.  Thomas  Picht 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Neurochirurgie, Charité-Universitätsmedizin Berlin
    • Mr.  PD Dr. med.  Thomas  Picht 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.