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Sensorineural Hearing LossCIPRESNCT07146841

Hearing Preservation in Cochlear Implantation Surgery

A study testing Round window insertion, Cochleostomy insertion and Lateral wall array in people with Sensorineural Hearing Loss, run by UMC Utrecht at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sensorineural Hearing Loss
What is being tested?
Round window insertion, Cochleostomy insertion and Lateral wall array
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteNetherlands
Study dates
29 Jan 2020to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe hearing loss, CI candidate
  • 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

Who cannot join

  • prior otologic surgery in the implanted ear (excluding tympanostomy tube placement)
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Imogen AML van Beurden, MD contact

+31887555555

i.a.m.l.vanbeurden-5@umcutrecht.nl

Netherlands1 site, 1 recruiting

  • University Medical Center Utrecht

    Utrecht

    Hans GXM Thomeer, MD, PhD, +310887555555, h.g.x.m.thomeer@umcutrecht.nl

    i.a.m.l.vanbeurden-5@umcutrecht.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial

In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a *straight* lateral wall lying electrode array (LW), or a *pre-curved* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.

Being tested
Round window insertion, Cochleostomy insertion, Lateral wall array, Periomodiolar electrode array
Keywords
Sensorineural Hearing Loss, Cochlear Implantation, Residual Hearing Preservation, Electrocochleography
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Round window insertionProcedure or surgery

    Also called Round window

    Insertion of the electrode array via the round window.

  • Cochleostomy insertionProcedure or surgery

    Also called cochleostomy

    Insertion of the electrode array via cochleostomy.

  • Lateral wall arrayDevice

    Lateral wall electrode array from Advanced Bionics.

  • Periomodiolar electrode arrayDevice

    Also called Perimodiolar array

    Perimodiolar MidScala electrode array from Advanced Bionics.

Study groups in NCT07146841
Study groupRoleWhat they receive
Group 1: RW and LWOtherCombination of round window insertion and lateral wall electrode array
Receives: Procedure: Round window insertion; Device: Lateral wall array
Group 2: RW and PMOtherCombination of round window insertion and perimodiolar electrode array
Receives: Procedure: Round window insertion; Device: Periomodiolar electrode array
Group 3: CO and LWOtherCombination of cochleostomie insertion and lateral wall electrode array
Receives: Procedure: Cochleostomy insertion; Device: Lateral wall array
Group 4: CO + PMOtherCombination of cochleostomy insertion and perimodiolar electrode array
Receives: Procedure: Cochleostomy insertion; Device: Periomodiolar electrode array

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hearing preservation

    Hearing preservation is the main outcome, which will be expressed in percentage. Hearing preservation is calculated by using the preoperative and postoperative puretoneaudiometry (PTA).

    Measured: 12 months

Secondary outcomes (3)

  1. Scalar position of the electrode array

    Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT)

    Measured: 12 months

  2. Electrocochleography

    ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials

    Measured: 12 months

  3. Speech perception

    Speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start29 Jan 2020
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Randomized controlled single-blind trial consisting of four groups: I: RW and LW, II: RW and PM, III: CO and LW and IV: CO and PM.
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07146841
Sponsor's protocol ID
NL71233.041.19
Other IDs
NL8586
Acronym
CIPRES
Status last verified
Aug 2025
First submitted
21 Aug 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 21756464

  • 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.

    PubMed 17063008

  • 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.

    PubMed 28045786

  • 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.

    PubMed 30624395

  • 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.

    PubMed 29936898

  • 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.

    PubMed 26176556

  • 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.

    PubMed 24764083

  • 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.

    PubMed 23640087

  • 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.

    PubMed 17063005

  • 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.

    PubMed 18223448

  • 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.

    PubMed 23446225

  • 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.

    PubMed 24556970

  • 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.

    PubMed 23044644

  • 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.

    PubMed 34886884

Questions about this trial

What is this clinical trial studying?

A study testing Round window insertion, Cochleostomy insertion and Lateral wall array in people with Sensorineural Hearing Loss, run by UMC Utrecht at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Imogen AML van Beurden, MD (+31887555555, i.a.m.l.vanbeurden-5@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hearing preservation (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07146841, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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Hearing Preservation in Cochlear Implantation Surgery | AzTrials