Trials / Completed
CompletedNCT06106373
iotaSOFT Pediatric Study
iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- iotaMotion, Inc. · Industry
- Sex
- All
- Age
- 9 Months – 12 Years
- Healthy volunteers
- Accepted
Summary
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iotaSOFT Insertion System | robotic assistive technology for cochlear implant electrode insertion |
Timeline
- Start date
- 2022-05-17
- Primary completion
- 2024-10-24
- Completion
- 2025-07-10
- First posted
- 2023-10-30
- Last updated
- 2025-09-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06106373. Inclusion in this directory is not an endorsement.