Pilot Clinical Study Using Pre-operative Simulation for Patients Undergoing Cochlear Implant

NCT04588870 | Withdrawn

• 1 other identifier: OSU2020H0080
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sensori-Neural Deafness

Outcome Measures

Primary Outcomes (1)

• Change of CNC score

  Aided speech perception testing in the CI ear, higher percent score (up to 100) means better hearing outcome. Range is from 0 to 100%.

  6 months after cochlear implantation compared to pre surgery.

Secondary Outcomes (3)

• AZBio scores

  6 months after cochlear implantation

• CNC scores

  12 months after cochlear implantation

• AZBio scores

  12 months after cochlear implantation

Other Outcomes (2)

• Scalar Location

  1 to 4 weeks after surgery (first post op imaging)

• Modiolar Distance

  1 to 4 weeks after surgery (first post op imaging)

Study Arms (1)

Preoperative Cochlear Implant

EXPERIMENTAL

The intervention will be the use of a surgical simulation system preoperatively by the surgeon to develop the surgical plan to optimize electrode array placement with respect to scalar location and modiolar distance.

Device: Pre operative computer based cochlear implant surgical simulation

Interventions

Pre operative computer based cochlear implant surgical simulation DEVICE

Prior to surgery, the surgeon will perform virtual cochlear implant surgery on patient specific imaging data within a computer simulation program. The surgeon will be able to iterate the procedure on the simulator until achieving the best electrode array location is achieved with respect to scalar location and modiolar distance. A written and graphical surgical plan will then be developed that the surgeon can use in the actual surgery.

Preoperative Cochlear Implant

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sensorineural Deafness
• Candidate for cochlear implantation

You may not qualify if:

• Inability to participate
• Not a candidate for cochlear implantation
• Age less than 18 or greater than 90

Sponsors & Collaborators

• Nationwide Children's Hospital: lead
• Ohio State University: collaborator
• Region Capital Denmark: collaborator

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology, Pediatrics and Biomedical Informatics

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 19, 2020
• Study Start: February 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: March 1, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share