Hearing Loss, CochlearACENCT06664697
Post-Market Clinical Investigation of the IotaSOFT Insertion System
An observational study of Hearing Loss, Cochlear and Cochlear Implantation, run by iotaMotion, Inc. at 3 sites in United States.
Trial summary
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hearing Loss, Cochlear, Cochlear Implantation, Hearing Loss, Sensorineural
- What is being tested?
- Cochlear Implantation with Robotic-Assisted Insertion System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A minimum of 50 subjects with sensorineural hearing loss and who have received a cochlear implant using the commercially available iotaSOFT insertion system or are scheduled for unilateral or bilateral cochlear implant surgery will be enrolled, such that a minimum of 50 subjects/ears using iotaSOFT will be attempted
Who may be able to join
- Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:
- Advanced Bionics HiFocus SlimJ
- Cochlear Slim Straight
- MED-EL Flex 24 and 28
- Age 12 years or older at the time of CI surgery.
- Willingness to participate in the study and able to comply with the follow-up visit requirements.
Who cannot join
- Prior cochlear implantation in the ear to be implanted.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
- Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.
- Deafness due to lesions of the acoustic nerve or central auditory pathway.
- Diagnosis of auditory neuropathy.
- Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
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- Absence of cochlear development.
- Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
- Non-native English speakers who are unable to read, understand and/or speak English for completion of required procedures
- Planned or current participation in a clinical study of an investigational device or drug.
- Must not fit the definition of a vulnerable subjects, as per FDA regulations 21 CFR Parts 50 and 56
Trial locations and contacts
3 sites in 1 country.
Wade Colburn contact
United States3 sites, 3 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Leila Partoo, 317-278-1238, lpartoo@iu.edu
Rick Nelson, MD
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Camille Dunn, AuD, 319-356-3574, camille-dunn@uiowa.edu
Bruce Gantz, MD
- Recruiting
Oregon Health and Sciences University
Portland, Oregon, 97239
Jess Mace, 503-494-5886, macej@ohsu.edu
Jay Gantz, MD
About this study
Official title: Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
Read the detailed description
available iotaSOFT Insertion System when used per intended use for insertion of a cochlear implant electrode array in subjects 12 years and older. The purpose of the study is to collect additional safety data in retrospective and prospective subjects. The primary object of the study is to demonstrate post-market safe use of the commercially available iotaSOFT Insertion System. The secondary objective of the study is to define procedural characteristics including device deficiencies, electrode array insertion speed, rate of tip fold-over, and objective measures of cochlear implant functionality to demonstrate effective use of the commercially available iotaSOFT Insertion System.
- Being tested
- Cochlear Implantation with Robotic-Assisted Insertion System
- Keywords
- cochlear implantation, sensorineural hearing loss
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear Implantation with Robotic-Assisted Insertion SystemDevice
The purpose of the study is to collect additional safety data in retrospective and prospective subjects who receive a cochlear implant using the iotaSOFT Insertion System.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Retrospective Review of patient records Receives: Device: Cochlear Implantation with Robotic-Assisted Insertion System | |
| Prospective | Prospective data collection of subjects receiving a cochlear implant with robotic-assisted cochlear implant Receives: Device: Cochlear Implantation with Robotic-Assisted Insertion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery through 1 month post-operative follow-up
Measured: 1 month post-activation
Secondary outcomes (1)
Number of device deficiencies related to the use of the iotaSOFT Insertion System
Number of reported device deficiencies related to the use of the iotaSOFT Insertion System at the time of cochlear implant surgery
Measured: 1 month post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Oct 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, CochlearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iotaMotion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664697
- Sponsor's protocol ID
- ICI2401
- Acronym
- ACE
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Cohort data will be provided for analysis for publication and presentation and individual data points will be pulled for reporting requirements only. Primary and secondary endpoint data will be exported and analyzed for required reporting.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
- ClinicalTrials.gov ID
- NCT06664697
- Acronym / sponsor ID
- ACE / ICI2401
- Keywords
- cochlear implantation, sensorineural hearing loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- iotaMotion, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
Detailed description
available iotaSOFT Insertion System when used per intended use for insertion of a cochlear implant electrode array in subjects 12 years and older. The purpose of the study is to collect additional safety data in retrospective and prospective subjects. The primary object of the study is to demonstrate post-market safe use of the commercially available iotaSOFT Insertion System. The secondary objective of the study is to define procedural characteristics including device deficiencies, electrode array insertion speed, rate of tip fold-over, and objective measures of cochlear implant functionality to demonstrate effective use of the commercially available iotaSOFT Insertion System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Device: Cochlear Implantation with Robotic-Assisted Insertion SystemRetrospective Review of patient records |
| Prospective | – | Device: Cochlear Implantation with Robotic-Assisted Insertion SystemProspective data collection of subjects receiving a cochlear implant with robotic-assisted cochlear implant |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A minimum of 50 subjects with sensorineural hearing loss and who have received a cochlear implant using the commercially available iotaSOFT insertion system or are scheduled for unilateral or bilateral cochlear implant surgery will be enrolled, such that a minimum of 50 subjects/ears using iotaSOFT will be attempted
Key inclusion criteria (6 listed)
- Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:
- Age 12 years or older at the time of CI surgery.
- Willingness to participate in the study and able to comply with the follow-up visit requirements.
Key exclusion criteria (12 listed)
- Prior cochlear implantation in the ear to be implanted.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
- Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.
- Deafness due to lesions of the acoustic nerve or central auditory pathway.
- Diagnosis of auditory neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear Implantation with Robotic-Assisted Insertion SystemThe purpose of the study is to collect additional safety data in retrospective and prospective subjects who receive a cochlear implant using the iotaSOFT Insertion System. | Device | Prospective, Retrospective |
Primary outcome
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery
Time frame: 1 month post-activation
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery through 1 month post-operative follow-up
1 secondary outcome
Number of device deficiencies related to the use of the iotaSOFT Insertion System
Time frame: 1 month post-activation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes. Cohort data will be provided for analysis for publication and presentation and individual data points will be pulled for reporting requirements only. Primary and secondary endpoint data will be exported and analyzed for required reporting.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wade Colburn contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Cochlear and Cochlear Implantation, run by iotaMotion, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Chenier, AuD (442-325-4171, lchenier@iotamotion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery (time frame: 1 month post-activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.