Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04588870 |
| Other study ID # |
OSU2020H0080 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2024 |
| Est. completion date |
March 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Nationwide Children's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
36 patients will be enrolled in a pilot trial. Eligible patients (receiving CI at OSU) that
consent to participate into the study will be enrolled. A simulation with visualize cochlear
substructures will be created for each patient, and surgeon will conduct virtual surgery with
various cochlear implant electrode types and using different techniques for optimal
positioning. Based on the feedback from the simulation platform, the surgeon will find the
optimal CI electrode and surgical technique using the virtual simulation and a formal plan
will be recorded to guide the actual surgery. Patient demographic information, medical
history and pre op audiogram will be collected once enrolled. Post-op images will be used to
identify the actual electrode location (scalar location (SL), modiolar distance (MD) and and
angular insertion depth (AID). At 6- and 12-months post-op, word score (CNC) will be obtained
as primary clinical outcomes and AZBio scores will also be obtained and evaluated as a
secondary clinical outcome. All outcomes data to be collected for SA3 are considered as part
of routine clinical care for patients undergoing CI at our institution. The prospective data
collection plan will ensure these data will be collected timely with high quality. OSU IRB
approval has been obtained for this study (OSU IRB# 2020H0080: Virtual Reality simulation for
patient specific surgical rehearsal in cochlear implantation - OSU#2) pending additional
amendments as needed.
Description:
Hypothesis: Patients undergoing pre-operative CI simulation will have improved outcomes as
measured by SL, MD and audiological outcomes.
The goal of this aim is to demonstrate clinical feasibility and to collect preliminary
efficacy data for using the pre-operative simulation with active feedback for CI patients.
This will be achieved by prospectively using the CI simulation system and evaluating both
technical and clinical audiological outcomes.
C.4.1 Pre-operative Simulation: Prior to surgery, a simulation with visualization of cochlear
microstructures will be created for each patient, and the surgeon will conduct iterative
virtual surgery with active feedback to determine the optimal surgical approach and cochlear
implant electrode position. Based on the feedback from the simulation platform, the surgeon
will determine the optimal CI electrode and surgical technique using the virtual simulation
to plan the actual surgery. Post-implant feedback will be displayed to the surgeon. Once
parameters (SL, MD, AID) are optimized, a surgical plan will be recorded and used during the
actual surgical procedure. A surgical plan will consist of the implant type, cochleostomy
site, and insertion techniques used for optimal placement. This will be added to the patient
electronic medical record to be referenced immediately prior to surgery. Additionally, the
simulator will save all performances with the optimized performance being made available for
review on the simulator at any time (3-dimensional playback).
C.4.2 Clinical Outcomes: Aided speech perception testing in the CI ear will be administered
at 6- and 12-months post activation using monosyllabic words (CNC Word test) presented at 60
dB SPL (A-weighted) as well as sentences (AzBio) in quiet and at +10 signal-to-noise ratio.
Percent correct will be calculated for each test and will serve as the primary clinical
outcomes.
C.4.3 User Evaluation: Simulator evaluation (user interface, usefulness, potential usage in
future, and overall satisfactory) and feedback/comments from the surgeon about the simulation
platform will continued to be collected pre and post-operatively to provide insight into
continued future improvement of the simulation platform.
C.4.5 Reproducibility and Rigor:
Statistical Analysis: Demographic information as well as post-op CI location parameters (SL,
MD, AID), pre/post-op CNC and AzBio scores will be summarized with descriptive statistics:
mean/SD, median/IQR for continuous variables and count/percentage for categorical data.
Changes of the CNC /AzBio scores overtime will be analyzed using linear mixed models to
account for the association of measures from the same patient at different time points, and
to deal with missing data assuming missing data will occur randomly. Exploratory analysis
will be conducted to (1) evaluate the association of the CI location parameters with the
post-op CNC scores; (2) compare the post-op CI location parameters with the CI patients
without pre-op simulations that are reported in the literature and/or those who have
undergone CI insertion in this institution (historical controls at OSU).
Sample Size: For this pilot study, a sample size of 30 patients is proposed to evaluate
selected feasibility issues, assess the adequacy of instrumentation, and collect preliminary
efficacy data (along with historical data) for the design of a larger prospective, randomized
trial. For the improvement of the clinical outcome (CNC) after CI, a sample size of 30
patients produces a one-sided 90% upper confidence limit of variance <1.5 when the sample
variance of the improvement of CNC is 1.0. Up to 36 patients will be enrolled to account for
potential attrition due to various unexpected reasons during the period from the enrollment
to implant surgery, to 6-month follow-up.
