Actively Recruiting
Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
Led by iotaMotion, Inc. · Updated on 2024-10-31
50
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the continued safety of the iotaSOFT Insertion System, a device used by surgeons to assist in inserting cochlear implant electrode arrays in one ear per participant. The study includes participants aged 12 years and older who have sensorineural hearing loss and are receiving or have received cochlear implants. The goal is to collect additional safety data and understand procedural details such as device performance and implant functionality. The study involves two groups: a retrospective review of patient records and a prospective collection of data from subjects receiving a cochlear implant with the robotic-assisted iotaSOFT Insertion System. The study focuses on the commercial use of this device as intended for cochlear implant surgery. Researchers will gather information on device deficiencies, insertion speed, tip fold-over rates, and measures related to cochlear implant function. Participants will be monitored through follow-up visits, with researchers assessing adverse events related to device use up to one month after activation of the implant. Safety data and procedural characteristics will be recorded to evaluate the use of the device. The total participation time includes both retrospective data review and prospective follow-up after surgery, ensuring comprehensive monitoring of outcomes and any device-related issues.
CONDITIONS
Brief Title
Post-Market Clinical Investigation of the IotaSOFT Insertion System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidates with sensorineural hearing loss receiving or having received unilateral or bilateral cochlear implantation with FDA approved devices (Advanced Bionics HiFocus SlimJ, Cochlear Slim Straight, MED-EL Flex 24 and 28)
- Age 12 years or older at the time of cochlear implant surgery
- Willingness and ability to participate in the study and comply with follow-up visits
You will not qualify if you...
- Prior cochlear implantation in the ear to be implanted
- Ossification or cochlear anomalies preventing complete electrode insertion or increasing risk
- Craniofacial abnormalities, temporal squamosal skull thickness less than 3mm, major cochlear lesions or malformations
- Deafness due to acoustic nerve or central auditory pathway lesions
- Diagnosis of auditory neuropathy
- Active middle ear infection or tympanic membrane perforation with active middle ear disease
- Absence of cochlear development
- Medical concerns preventing participation in evaluations as determined by the investigator
- Unrealistic expectations regarding benefits, risks, and limitations of the procedure and device
- Non-native English speakers unable to complete required procedures
- Current or planned participation in another clinical study of an investigational device or drug
- Defined as vulnerable subjects under FDA regulations 21 CFR Parts 50 and 56
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo cochlear implant surgery using the iotaSOFT Insertion System for electrode array insertion.
1 visit (in-person)
Duration - 1 month post-activation
Participants are monitored for safety and device performance after surgery including assessment of adverse events and device deficiencies.
Approximately 1 to 2 visits depending on activation schedule
Trial Site Locations
Total: 3 locations
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
3
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
L
Laura Chenier, AuD
W
Wade Colburn
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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