At a glance
ClinicalIndex Comparison RecordN/ACompleted· 25 enrolled
Drug / intervention
iotaSOFT Insertion Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The iotaSOFT Insertion System Safety Study
In Brief
A clinical study evaluating iotaSOFT Insertion System for Cochlear Implant. Completed, enrolled 25 participants across 1 site.
Detailed Summary
Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCochlear Implant
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
Enrollment StartSep 2020
First PostedOct 2020
Primary CompletionApr 2021
TodayJul 2026
First PostedOct 6, 2020
Enrollment StartSep 18, 2020
Primary CompletionApr 2, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.7 years ago
Interventions
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.