University Medical Center Utrecht
Utrecht, Netherlands
Location status: Recruiting
NCT Number: NCT07146841
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Utrecht, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insertion of the electrode array via the round window.
Other names: Round window
Insertion of the electrode array via cochleostomy.
Other names: cochleostomy
Lateral wall electrode array from Advanced Bionics.
Perimodiolar MidScala electrode array from Advanced Bionics.
Other names: Perimodiolar array
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).
Time frame: 12 months
Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT)
Time frame: 12 months
ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials
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.
Interested in participating?
Request InfoUMC Utrecht
Other
Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial
Acronym: CIPRES
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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