Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07146841
NA

Hearing Preservation in Cochlear Implantation Surgery

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2020-01-29

Completion Date

2027-01-01

Last Updated

2025-08-28

Healthy Volunteers

No

Interventions

PROCEDURE

Round window insertion

Insertion of the electrode array via the round window.

PROCEDURE

Cochleostomy insertion

Insertion of the electrode array via cochleostomy.

DEVICE

Lateral wall array

Lateral wall electrode array from Advanced Bionics.

DEVICE

Periomodiolar electrode array

Perimodiolar MidScala electrode array from Advanced Bionics.

Locations (1)

University Medical Center Utrecht

Utrecht, Netherlands