Cochlear Implant
Conditions
Brief summary
Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.
Detailed description
This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of the system during cochlear implant surgery.
Interventions
Enrolled subjects undergoing cochlear implant surgery will have the iotaSOFT Insertion System used by the surgeon to assist with implantation of the implant electrode array during the procedure.
Sponsors
iotaMotion, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Candidate for cochlear implantation per indications * Age 18 years or older Key
Exclusion criteria
* Prior cochlear implantation in ear to be treated * Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray * Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging * Deafness due to lesions of the acoustic nerve or central auditory pathway * Diagnosis of auditory neuropathy * Active middle ear infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery | Day 0 | Number of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended. | Day 0 | The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range) | Day 0 | The duration of time it takes for electrode array insertion will be measured |
| Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure | Day 0 | Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode. |
| Adverse Events Reported During the Follow-up Period as Documented by Impedance and Neural Response Telemetry Testing. Adverse Events Will be Categorized by Type and Number of Participants Experiencing an Event. | 1 month | Potential risks and benefits of iotaSOFT will be assessed and characterized through data obtained during the post-surgical follow-up period while conducting impedance measurements and neural response telemetry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| iotaSOFT Insertion System Overall number of baseline participants: 25 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | iotaSOFT Insertion System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 21 Participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 11 / 21 |
| serious Total, serious adverse events | 2 / 21 |
Outcome results
Primary
Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery
Number of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event.
Time frame: Day 0
Population: All enrolled subjects in study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iotaSOFT Insertion System | Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery | 2 Participants |
Secondary
Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended.
The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use.
Time frame: Day 0
Population: All subjects enrolled in the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iotaSOFT Insertion System | Successful Surgical Use of the iotaSOFT Insertion System During Cochlear Implant Surgery as Measured by a Surgeon Utility Questionnaire. The Questionnaire Will be Used to Calculate the Proportion of Subjects in Which the Device Performed as Intended. | 21 Participants |
Other Pre-specified
Adverse Events Reported During the Follow-up Period as Documented by Impedance and Neural Response Telemetry Testing. Adverse Events Will be Categorized by Type and Number of Participants Experiencing an Event.
Potential risks and benefits of iotaSOFT will be assessed and characterized through data obtained during the post-surgical follow-up period while conducting impedance measurements and neural response telemetry.
Time frame: 1 month
Population: Enrolled and completed subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iotaSOFT Insertion System | Adverse Events Reported During the Follow-up Period as Documented by Impedance and Neural Response Telemetry Testing. Adverse Events Will be Categorized by Type and Number of Participants Experiencing an Event. | 0 Participants |
Other Pre-specified
Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range)
The duration of time it takes for electrode array insertion will be measured
Time frame: Day 0
Population: All enrolled and study completed subjects
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iotaSOFT Insertion System | Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range) | 2.5 Minutes |
Other Pre-specified
Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure
Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode.
Time frame: Day 0
Population: Enrolled and completed subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iotaSOFT Insertion System | Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure | 21 Participants |