Trials / Completed
CompletedNCT04577118
The iotaSOFT Insertion System Safety Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- iotaMotion, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iotaSOFT Insertion System | 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. |
Timeline
- Start date
- 2020-09-18
- Primary completion
- 2021-04-02
- Completion
- 2021-04-02
- First posted
- 2020-10-06
- Last updated
- 2024-04-30
- Results posted
- 2024-03-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04577118. Inclusion in this directory is not an endorsement.