Evaluating a New Software (OTOGUIDE) to Help Monitor Electrode Insertion During Cochlear Implant Surgery. (OGUID)
Monitoring Electrode Insertion During Cochlear Implant Surgery With OTOGUIDE
Cochlear implants are a successful treatment for severe hearing loss in both children and adults. The procedure involves placing an electrode array into the cochlea to stimulate the auditory nerve, helping patients to hear. For the best results, it's crucial to place the electrode precisely and gently to avoid damaging delicate structures inside the ear. However, currently, surgeons lack feedback on the insertion status, making it difficult to confirm correct electrode positioning, especially regarding insertion depth, such as angle, frequency, or millimeters. New technologies are being developed to provide feedback during surgery, helping surgeons place the electrode more accurately. One such technology, recently developed by MED-EL, is called OTOGUIDE. This software offers immediate information on the electrode's position and functioning during the operation, aiming to improve surgical precision and hearing outcomes.
This clinical investigation aims to evaluate the performance and safety of OTOGUIDE, which assists surgeons during cochlear implant procedures by helping identify the position and angle of electrode contacts placed inside the cochlea. The primary objective is to confirm that OTOGUIDE can accurately detect which electrodes are inserted into the cochlea, with results that are more than 80% consistent with standard CT imaging (either during or after surgery). The secondary objective is to verify that OTOGUIDE can estimate the insertion angle of a specific electrode (C1) with a margin of error smaller than 60 degrees compared to CT imaging.
Participants who agree to take part and sign the informed consent form will undergo up to three study visit, which coincides with their scheduled routine cochlear implant surgery visits. During the Surgery Visit intraoperative measurements will be performed using both OTOGUIDE and the MAESTRO system. CT imaging (either during or after surgery, depending on routine clinical practice) will be used to verify the electrode array's position inside the cochlea.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Jasmine Rinnofner
- Telefoonnummer: +43577881694
- E-mail: jasmine.rinnofner@medel.com
Studie Locaties
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Bavaria
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Munich, Bavaria, Duitsland, 81377
- Nog niet aan het werven
- Klinikum der Universität München, Campus Großhadern Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde
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Contact:
- Florian Simon, Dr.med.
- Telefoonnummer: +49894400-81449
- E-mail: florian.simon@med.uni-muenchen.de
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Tyrol
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Innsbruck, Tyrol, Oostenrijk, 6020
- Werving
- Medizinische Universität Innsbruck
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Contact:
- Joachim Schmutzhard, Prof. Dr. med.
- Telefoonnummer: +43 512 504 23141
- E-mail: Joachim.Schmutzhard@i-med.ac.at
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Minimum age of eighteen (18) years at time of enrolment.
- Subjects to be implanted with a compatible MED-EL cochlear implant (CI) (Mi1200 SYNCHRONY (PIN), Mi1210 SYNCHRONY ST, Mi1250 SYNCHRONY 2 (PIN), Mi1260 SONATA 2) according to clinical routine.
- Signed and dated informed consent before the start of any study-specific procedure.
Exclusion Criteria:
- Previously having received a CI on the ear to be tested (Re-implantation).
- Evidence of ossification or any other cochlear anomaly (e.g., malformation) that might prevent complete insertion of the electrode array or might cause increased risk of infection (e.g. dysplastic cochlear), as confirmed by medical examination and/or as per CT/MRI.
- Known absence of cochlear development or if the cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway.
- Evidence of active external or middle ear infection or history of recurrent middle ear infection in the ear to be implanted.
- Acute cholesteatoma
- The tympanic membrane is perforated in the ear to be implanted.
- Pre-existing condition known to prohibit CT imaging before and after cochlear implantation.
- Women being pregnant or nursing.
- Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Monitoring electrode insertion with OTOGUIDE
Monitoring electrode insertion with OTOGUIDE during routine cochlear implantation
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OTOGUIDE performs objective measurements to enable the monitoring of the electrode insertion and the functioning of the electrode.
OTOGUIDE guides the users through a workflow-based session to assess the implant status and to define a surgical approach.
The users can plan an insertion target and monitor the real-time electrode insertion using an impedance-based method to automatically detect the number of contacts inside the cochlea.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Number of inserted electrodes
Tijdsspanne: through study completion, an average of 1 year
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The primary endpoint is the agreement rate between OTOGUIDE and intra- or post-operative CT imaging in detecting which contacts in an electrode array are inserted and which are not inserted in the cochlea.
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through study completion, an average of 1 year
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Insertion angle of C1 electrode contact
Tijdsspanne: through study completion, an average of 1 year
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The secondary endpoint is the deviation (i.e., the absolute difference) between the insertion angle for the C1 electrode contact estimated by OTOGUIDE and the insertion angle as assessed with intra- or post-operative CT imaging.
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through study completion, an average of 1 year
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Deviation in Hz of the frequencies allocated to C1 - C12 electrode contacts
Tijdsspanne: through study completion, an average of 1 year
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Deviation in Hz of the frequencies allocated to C1 - C12 electrode contacts as estimated by OTOGUIDE and the allocated frequencies as assessed with CT imaging
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through study completion, an average of 1 year
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Deviation in degree of the insertion angles of C2 - C12 electrode contacts
Tijdsspanne: through study completion, an average of 1 year
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Deviation in degree of the insertion angles of C2 - C12 electrode contacts estimated by OTOGUIDE and the insertion angles as assessed with intra-or post-operative CT imaging
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through study completion, an average of 1 year
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Intra-operative impedance values
Tijdsspanne: through study completion, an average of 1 year
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Deviation in kΩ of the intra-operative impedance values derived from OTOGUIDE and MAESTRO
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through study completion, an average of 1 year
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Product-specific feedback
Tijdsspanne: through study completion, an average of 1 year
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OTOGUIDE usability and satisfaction questionnaire for clinicians
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through study completion, an average of 1 year
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- MED-EL_CRD_2024_04
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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