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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
University Medical Center Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Imogen AML van Beurden, MD
i.a.m.l.vanbeurden-5@umcutrecht.nl
+31887555555
Time Frame
Start Date: 2020-01-29
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 48
Treatments
Other: Group 1: RW and LW
Combination of round window insertion and lateral wall electrode array
Other: Group 2: RW and PM
Combination of round window insertion and perimodiolar electrode array
Other: Group 3: CO and LW
Combination of cochleostomie insertion and lateral wall electrode array
Other: Group 4: CO + PM
Combination of cochleostomy insertion and perimodiolar electrode array
Related Therapeutic Areas
Sponsors
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov