Trial document




drksid header

  DRKS00000447

Trial Description

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Title

Continuuous intraoperative neuromonitoring during neck surgery - a prospective, randomized trial

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Trial Acronym

IKONA CIONM

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The clinical investigation shall be conducted to examine a new monitoring system for recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery.

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Brief Summary in Scientific Language

Recurrent laryngeal nerve palsy is a dreaded complication in thyroid surgery. Despite the improved identification of the nerve with intermittent nerve stimulation and monitoring, a decrease of nerve palsy rates could not yet be shown.
The system under evaluation has been newly developed for continuous intraoperative neuromonitoring. The system comprises a stimulation electrode that has been designed for vagus nerve stimulation.

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Organizational Data

  •   DRKS00000447
  •   2010/06/21
  •   [---]*
  •   yes
  •   Approved
  •   460/2009MPG1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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

  •   E04 -  Other nontoxic goitre
  •   C73 -  Malignant neoplasm of thyroid gland
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Interventions/Observational Groups

  •   standard elektrode V3, Inomed GmbH
  •   newly developed stimulation electrode IKS-1 ("Saxophon"-Elektrode)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Safety and effectiveness of the new svagus nerve stimulation electrode

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Secondary Outcome

Reduction of clinical complications in thyroid surgery by continuous interapoerative neuromonitoring (CIONM)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2010/07/01
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   21   Years
  •   99   Years
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Additional Inclusion Criteria

1. planned, elective neck surgery
2. ability of the patient to give informed consent

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Exclusion Criteria

1. Preexisting palsy of the recurrent laryngeal nerve
2. Patients suffering from severe cardiac arrhythmia (tachycardic/ bradycardic heart rhythm with hemodynamic instability)
3. Patients with a cardiac pacemaker
4. Pregnancy/ breast feeding mums/patients
5. Missing informed consent/
Patient is unable to provide informed consent


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Addresses

  • start of 1:1-Block address primary-sponsor
    • Robert-Bosch-Krankenhaus Stuttgart
    • Mr.  PD Dr. med.   Wolfram   Lamadé 
    • Auerbachstrasse 110
    • 70376  Stuttgart
    • Germany
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    • Abteilung für Allgemein- und Viszeralchirurgie, Robert-Bosch-Krankenhaus Stuttgart
    • Mr.  Dr. med  Wolfram  Lamadé 
    • Auerbachstrasse 110
    • 70376  Stuttgart
    • Germany
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    • Abteilung für Allgemein- und Viszeralchirurgie, Robert-Bosch-Krankenhaus Stuttgart
    • Mr.  PD Dr. med  Wolfram  Lamadé 
    • Auerbachstrasse 110
    • 70376  Stuttgart
    • Germany
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Sources of Monetary or Material Support

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    • BMBF Projekt IKONA, Förderkennzeichen 01EZ0725
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
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    •   +49 (0)228/ 9957-0
    •   +49 (0)228/ 9957-83601
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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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.