Cochlear ImplantNCT04577118
The iotaSOFT Insertion System Safety Study
A study testing iotaSOFT Insertion System in people with Cochlear Implant, run by iotaMotion, Inc. at 1 site in United States.
Trial summary
Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant
- What is being tested?
- iotaSOFT Insertion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidate for cochlear implantation per indications
- Age 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.
Read the 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.
- Conditions
- Cochlear Implant
- Being tested
- iotaSOFT Insertion System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iotaSOFT Insertion SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iotaSOFT Insertion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (1)
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start18 Sep 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cochlear ImplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- iotaMotion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Gantz, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577118
- Sponsor's protocol ID
- iotaSOFT000001
- Status last verified
- Feb 2024
- First submitted
- 22 Sep 2020
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iotaSOFT Insertion System Safety Study
- ClinicalTrials.gov ID
- NCT04577118
- Acronym / sponsor ID
- iotaSOFT000001
- Conditions
- Cochlear Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- iotaMotion, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iotaSOFT Insertion System | Other | Device: iotaSOFT Insertion SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Candidate for cochlear implantation per indications
- Age 18 years or older
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| iotaSOFT Insertion SystemEnrolled 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. | Device | iotaSOFT Insertion System |
Primary outcome
Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery
Time frame: 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.
1 secondary outcome
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.
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Bruce Gantz, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iotaSOFT Insertion System in people with Cochlear Implant, run by iotaMotion, Inc. at 1 site 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery (time frame: Day 0). 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 30 Apr 2024.