Trial document
DRKS00000447
Trial Description
Title
Continuuous intraoperative neuromonitoring during neck surgery - a prospective, randomized trial
Trial Acronym
IKONA CIONM
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.
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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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
Secondary IDs
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Health Condition or Problem studied
- E04 - Other nontoxic goitre
- C73 - Malignant neoplasm of thyroid gland
Interventions/Observational Groups
- standard elektrode V3, Inomed GmbH
- newly developed stimulation electrode IKS-1 ("Saxophon"-Elektrode)
Characteristics
- Interventional
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- Randomized controlled trial
- Open (masking not used)
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- Active control
- Prevention
- Parallel
- N/A
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Primary Outcome
Safety and effectiveness of the new svagus nerve stimulation electrode
Secondary Outcome
Reduction of clinical complications in thyroid surgery by continuous interapoerative neuromonitoring (CIONM)
Countries of Recruitment
- Germany
Locations of Recruitment
- [---]*
Recruitment
- Planned
- 2010/07/01
- 100
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 21 Years
- 99 Years
Additional Inclusion Criteria
1. planned, elective neck surgery
2. ability of the patient to give informed consent
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
Addresses
-
start of 1:1-Block address primary-sponsor
- Robert-Bosch-Krankenhaus Stuttgart
- Mr. PD Dr. med. Wolfram Lamadé
- Auerbachstrasse 110
- 70376 Stuttgart
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0711 8101 5923
- 0711 8101 3782
- wolfram.lamadé at rbk.de
- http://www.rbk.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Abteilung für Allgemein- und Viszeralchirurgie, Robert-Bosch-Krankenhaus Stuttgart
- Mr. Dr. med Wolfram Lamadé
- Auerbachstrasse 110
- 70376 Stuttgart
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0711 8101 5923
- 0711 8101 3782
- wolfram.lamade at rbk.de
- http://www.rbk.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Abteilung für Allgemein- und Viszeralchirurgie, Robert-Bosch-Krankenhaus Stuttgart
- Mr. PD Dr. med Wolfram Lamadé
- Auerbachstrasse 110
- 70376 Stuttgart
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0711 8101 5923
- 0711 8101 3782
- wolfram.lamade at rbk.de
- http://www.rbk.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- BMBF Projekt IKONA, Förderkennzeichen 01EZ0725
- Heinemannstr. 2
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +49 (0)228/ 9957-0
- +49 (0)228/ 9957-83601
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end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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