Brief description of trial (Data source: BASEC)
In dieser Studie wird die Anwendbarkeit eines chirurgischen Navigationssystems in Ohr-Operationen untersucht. Ein chirurgisches Navigationssystem zeigt die Position von chirurgischen Werkzeugen in Patienten-spezifischen Computertomographie Bildern während eines Eingrisffs an.
In dieser Studie wird die Genauigkeit eines Navigationssystems gemessen.
Health conditions investigated(Data source: BASEC)
Chirurgische Eingriffe am Ohr welche eine Aushöhlung des Mastoidknochens benötigen
Health conditions
(Data source: WHO)
Otologic Disease
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Chirurgische Eingriffe am Ohr
Interventions
(Data source: WHO)
Device: Lateral skull base navigation
Criteria for participation in trial
(Data source: BASEC)
Patienten welche
- standardmässig eine Ohr-Operation durchführen müssen
- eine Einverständniserklärung unterschrieben haben
- über 18 Jahre alt sind
Exclusion criteria
(Data source: BASEC)
Patienten welche
- sich in einem Zustand befinden unter welchem die Studie das Operationsrisiko signifikant erhöhen würde (Beurteilung durch den Arzt)
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
- Patients which are regularly scheduled for an otologic surgical procedure
- Informed Consent as documented by signature
- Age >= 18 years
Exclusion Criteria:
- Other clinically condition or disease that would (as deemed by the operating surgeon)
significantly increase the risk of surgery
-
Further information on trial
Date trial registered
Feb 19, 2019
Incorporation of the first participant
Jan 1, 2020
Recruitment status
Terminated
Academic title
(Data source: WHO)
Feasibility of Stereotactic Image Guidance on the Lateral Skull Base
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Quantitative accuracy
Secundary end point
(Data source: WHO)
Qualitative accuracy
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Bern
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Marco Caversaccio
+41 (0)31 632 29 21
marco.caversaccio@insel.ch
Contact for general information
(Data source: WHO)
Marco Caversaccio, Prof.
Inselspital university hospital of Bern
+41 31 632 29 21
marco.caversaccio@insel.ch
Contact for scientific information
(Data source: WHO)
Marco Caversaccio, Prof.
Inselspital university hospital of Bern
+41 31 632 29 21
marco.caversaccio@insel.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Bern
Date of authorisation by the ethics committee
02.05.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-00128
Secondary ID (Data source: WHO)
0001-0001
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