Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2020-01-29
2027-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
SINGLE
Study Groups
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Group 1: RW and LW
Combination of round window insertion and lateral wall electrode array
Round window insertion
Insertion of the electrode array via the round window.
Lateral wall array
Lateral wall electrode array from Advanced Bionics.
Group 2: RW and PM
Combination of round window insertion and perimodiolar electrode array
Round window insertion
Insertion of the electrode array via the round window.
Periomodiolar electrode array
Perimodiolar MidScala electrode array from Advanced Bionics.
Group 3: CO and LW
Combination of cochleostomie insertion and lateral wall electrode array
Cochleostomy insertion
Insertion of the electrode array via cochleostomy.
Lateral wall array
Lateral wall electrode array from Advanced Bionics.
Group 4: CO + PM
Combination of cochleostomy insertion and perimodiolar electrode array
Cochleostomy insertion
Insertion of the electrode array via cochleostomy.
Periomodiolar electrode array
Perimodiolar MidScala electrode array from Advanced Bionics.
Interventions
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Round window insertion
Insertion of the electrode array via the round window.
Cochleostomy insertion
Insertion of the electrode array via cochleostomy.
Lateral wall array
Lateral wall electrode array from Advanced Bionics.
Periomodiolar electrode array
Perimodiolar MidScala electrode array from Advanced Bionics.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* normal function of middle ear (i.e. no acute middle ear infections)
* dutch language proficiency
* choice for Advanced Bionics implant
Exclusion Criteria
* inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation)
* retrocochlear pathology present in the auditory system to be implanted
* neurocognitive disorders
* sudden deafness
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Prof Dr HGXM Thomeer MD PhD
MD PhD
Principal Investigators
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Hans GXM Thomeer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Role: backup
References
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Rask-Andersen H, Erixon E, Kinnefors A, Lowenheim H, Schrott-Fischer A, Liu W. Anatomy of the human cochlea--implications for cochlear implantation. Cochlear Implants Int. 2011 May;12 Suppl 1:S8-13. doi: 10.1179/146701011X13001035752174.
Escude B, James C, Deguine O, Cochard N, Eter E, Fraysse B. The size of the cochlea and predictions of insertion depth angles for cochlear implant electrodes. Audiol Neurootol. 2006;11 Suppl 1:27-33. doi: 10.1159/000095611. Epub 2006 Oct 6.
Avci E, Nauwelaers T, Hamacher V, Kral A. Three-Dimensional Force Profile During Cochlear Implantation Depends on Individual Geometry and Insertion Trauma. Ear Hear. 2017 May/Jun;38(3):e168-e179. doi: 10.1097/AUD.0000000000000394.
Snels C, IntHout J, Mylanus E, Huinck W, Dhooge I. Hearing Preservation in Cochlear Implant Surgery: A Meta-Analysis. Otol Neurotol. 2019 Feb;40(2):145-153. doi: 10.1097/MAO.0000000000002083.
Fan X, Xia M, Wang Z, Zhang H, Liu C, Wang N, Hou L, Li C, Xu A. Comparison of electrode position between round window and cochleostomy inserting approaches among young children: a cone-beam computed tomography study. Acta Otolaryngol. 2018 Sep;138(9):815-821. doi: 10.1080/00016489.2018.1478127. Epub 2018 Jun 23.
Wanna GB, Noble JH, Gifford RH, Dietrich MS, Sweeney AD, Zhang D, Dawant BM, Rivas A, Labadie RF. Impact of Intrascalar Electrode Location, Electrode Type, and Angular Insertion Depth on Residual Hearing in Cochlear Implant Patients: Preliminary Results. Otol Neurotol. 2015 Sep;36(8):1343-8. doi: 10.1097/MAO.0000000000000829.
Wanna GB, Noble JH, Carlson ML, Gifford RH, Dietrich MS, Haynes DS, Dawant BM, Labadie RF. Impact of electrode design and surgical approach on scalar location and cochlear implant outcomes. Laryngoscope. 2014 Nov;124 Suppl 6(0 6):S1-7. doi: 10.1002/lary.24728. Epub 2014 May 30.
Havenith S, Lammers MJ, Tange RA, Trabalzini F, della Volpe A, van der Heijden GJ, Grolman W. Hearing preservation surgery: cochleostomy or round window approach? A systematic review. Otol Neurotol. 2013 Jun;34(4):667-74. doi: 10.1097/MAO.0b013e318288643e.
Gfeller KE, Olszewski C, Turner C, Gantz B, Oleson J. Music perception with cochlear implants and residual hearing. Audiol Neurootol. 2006;11 Suppl 1:12-5. doi: 10.1159/000095608. Epub 2006 Oct 6.
Buechner A, Brendel M, Krueger B, Frohne-Buchner C, Nogueira W, Edler B, Lenarz T. Current steering and results from novel speech coding strategies. Otol Neurotol. 2008 Feb;29(2):203-7. doi: 10.1097/mao.0b013e318163746.
Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163.
Skarzynski H, Lorens A, Matusiak M, Porowski M, Skarzynski PH, James CJ. Cochlear implantation with the nucleus slim straight electrode in subjects with residual low-frequency hearing. Ear Hear. 2014 Mar-Apr;35(2):e33-43. doi: 10.1097/01.aud.0000444781.15858.f1.
Eshraghi AA, Nazarian R, Telischi FF, Rajguru SM, Truy E, Gupta C. The cochlear implant: historical aspects and future prospects. Anat Rec (Hoboken). 2012 Nov;295(11):1967-80. doi: 10.1002/ar.22580. Epub 2012 Oct 8.
Jwair S, Boerboom RA, Versnel H, Stokroos RJ, Thomeer HGXM. Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial. Trials. 2021 Dec 9;22(1):895. doi: 10.1186/s13063-021-05878-2.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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NL8586
Identifier Type: OTHER
Identifier Source: secondary_id
NL71233.041.19
Identifier Type: -
Identifier Source: org_study_id
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