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Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iotaSOFT Insertion System | Other | The iotaSOFT Insertion System is a surgical device that aids the surgeon in implanting cochlear electrode arrays by controlling the speed and distance of implant insertion. All subjects enrolled in the trial will have the iotaSOFT Insertion System used during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iotaSOFT Insertion System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 0 |
| Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Gantz, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | iotaSOFT Insertion System | Purpose of this study is to evaluate safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant array. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Cochlear implant candidates 18 years and older at the time of surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | iotaSOFT Insertion System | Overall number of baseline participants: 25 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 18 years and older | 4 subjects withdrawn |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All enrolled subjects in study | Posted | Count of Participants | Participants | Day 0 |
|
Surgery to 1 month post-operative
Device related AEs and general AEs collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iotaSOFT Insertion System | Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered mental state | Psychiatric disorders | Non-systematic Assessment | Altered mental state as reported by daughter to ER doctor. Patient has not returned for follow-up visit due to non-associated medical problems. Ongoing contact being made to clinic to reschedule. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Resistance with iotaSOFT | Ear and labyrinth disorders | Non-systematic Assessment | Resistance noted at 20mm with electrode array insertion attempted to 24mm. Intra-operative fluoroscopy showed electrode was coiled in the cochlea. After the tip fold over, per protocol, electrode was removed and inserted manually. Resolved. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Chenier | iotaMotion, Inc | 442-325-4171 | lchenier@iotamotion.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2020 | Feb 1, 2024 | Prot_000.pdf |
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| Day 0 |
Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode. |
| Day 0 |
| 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. | 1 month |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 4 subjects were withdrawn from the study. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | 4 patients withdrawn | Count of Participants | Participants | No |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| 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. | All subjects enrolled in the study | Posted | Count of Participants | Participants | Day 0 |
|
|
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| 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 | All enrolled and study completed subjects | Posted | Mean | Full Range | Minutes | Day 0 |
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| 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. | Enrolled and completed subjects | Posted | Count of Participants | Participants | Day 0 |
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|
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| 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. | Enrolled and completed subjects | Posted | Count of Participants | Participants | 1 month |
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| 0 |
| 21 |
| 2 |
| 21 |
| 11 |
| 21 |
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| Patient hospitalization following knee surgery | Surgical and medical procedures | Non-systematic Assessment | Patient hospitalization following knee surgery. Knee pain pre-existing prior to surgery per patient/daughter report (ortho note history in medical file) |
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| No stimulation with device | Ear and labyrinth disorders | Non-systematic Assessment | . Imaging was re-examined and identified a pre-existing temporal bone fracture crossing the internal auditory canal with scarring of the cochlear nerve (implant side). Subject withdrawn from study. |
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| Drainage at implant site | Ear and labyrinth disorders | Non-systematic Assessment | Patient reported drainage at implant site. This is identified risk of cochlear implantation surgery as captured in labeling and literature. |
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| Bruising and dizziness | Ear and labyrinth disorders | Non-systematic Assessment | Bruising and dizziness reported by patient following surgery. This is identified risk of cochlear implantation surgery as captured in labeling and literature. |
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| CSF Leak | Ear and labyrinth disorders | Non-systematic Assessment | Investigator used otologic drill for pilot hole for motor platform resulted in small CSF leak. Repaired and stopped with fascia and bone wax intraoperatively. No leak at closure. Surgery completed without further consequence or complications. |
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| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment | No hospitalization necessary. Was seen by provider on 3-3-21. Recommended vestibular rehab locally. Based on time to onset of reported symptoms (74 days after surgery) it is unlikely this is related to use of the iotaSOFT during implantation. |
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| Incision coming open at CI site as seen at 2-week post-op visit. | Ear and labyrinth disorders | Non-systematic Assessment | Physician addressed by adding small additional suture. At subsequent visit (activation), healing issue resolved and activation occurred. This is identified risk of cochlear implantation surgery as captured in labeling and literature |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment | Tinnitus when pushes on implant site. Patient reported tinnitus prior to surgery and by 1-month visit tinnitus 'better'. This is identified risk of cochlear implantation surgery as captured in labeling and literature. |
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| Pain at incision | Ear and labyrinth disorders | Non-systematic Assessment | Pain at incision w/ headache. This is identified risk of cochlear implantation surgery as captured in labeling and literature. |
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| Swelling of face and eye area | Eye disorders | Non-systematic Assessment | Swelling in face and eye area on side of implant site. This is identified risk of cochlear implantation surgery as captured in labeling and literature. Vastly improved at 2-week follow-up |
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| Facial Stim | Ear and labyrinth disorders | Non-systematic Assessment | Facial stim and poor electrode response. At follow-up appointment (activation) the facial stim resolved with widening the pulse width of signal. Electrodes 11 and 12 still no response as surgeon elected shallow insertion |
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