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NCT Number: NCT07146841

Hearing Preservation in Cochlear Implantation Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht

Utrecht, Netherlands

Location status: Recruiting

Location contact

Hans GXM Thomeer, MD, PhD

CONTACT

[email protected]

+310887555555

Hans GXM Thomeer, MD, PhD

PRINCIPAL_INVESTIGATOR

Huib Versnel, PhD

SUB_INVESTIGATOR

Imogen AML van Beurden, MD

SUB_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Round window insertion

Procedure

Insertion of the electrode array via the round window.

Other names: Round window

Cochleostomy insertion

Procedure

Insertion of the electrode array via cochleostomy.

Other names: cochleostomy

Lateral wall array

Device

Lateral wall electrode array from Advanced Bionics.

Periomodiolar electrode array

Device

Perimodiolar MidScala electrode array from Advanced Bionics.

Other names: Perimodiolar array

Primary outcomes

  1. Hearing preservation

    Time frame: 12 months

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

Secondary outcomes

  1. Scalar position of the electrode array

    Time frame: 12 months

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

  2. Electrocochleography

    Time frame: 12 months

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

  3. Speech perception

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Imogen AML van Beurden, MD

CONTACT

[email protected]

+31887555555

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

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

Acronym: CIPRES

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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