NCT06664710 · iotaMotion, Inc.
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
(AIMBOT)
What this study is about
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
View original scientific description
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
Interventions
DEVICE
iotaSOFT Insertion System with AIM
Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
DEVICE
iotaSOFT Insertion System with AIM Control
iotaSOFT Insertion System with AIM using standard of care insertion techniques
Primary outcome measures
Device Feasibility
Time frame: Procedure Day 0
Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Cochlear implant candidate in one or two ears per current FDA indications
- Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
- Cochlear implantation using the Advanced Bionics SlimJ electrode array
- 18 years of age or older at the time of enrollment
- Willingness to participate in and comply with all requirements of the protocol
Exclusion criteria
- Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion. 4\. History of temporal bone fracture that involves the cochlea/internal auditory canal. 5\. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway). 6\. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease. 7\. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation. 8\. Additional medical concerns that would prevent participation in evaluations as determined by the investigator. 9\. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device. 10\. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Where
- Iowa City, Iowa
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2025 · Source of record for eligibility and locations