Trial Outcomes & Findings for iotaSOFT Pediatric Study (NCT NCT06106373)
NCT ID: NCT06106373
Last Updated: 2026-08-06
Results Overview
The primary endpoint of the study was to demonstrate safety of the iotaSOFT Insertion System through evaluation of iotaSOFT related serious adverse events through 30 days after CI surgery/activation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
(SAEs) through 30 days after CI surgery/activation
Results posted on
2026-08-06
Participant Flow
Study participants were identified and recruited by investigators from IDE/IRB-approved investigator sites. Those recruited were pediatric cochlear implant candidates pending implantation with one of the protocol-identified iotaSOFT-compatible electrode arrays.
20 study participants were enrolled and received the investigational intervention.
Participant milestones
| Measure |
Pediatric Cochlear Implant Recipient
Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
Cochlear Implant Surgery
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pediatric Cochlear Implant Recipient
n=20 Participants
Pediatric subjects receiving a cochlear implant (iotaSOFT compatible) between the ages of 9 months and under 12 years of age; meet prescribed inclusion and exclusion criteria per protocol; signing Informed Consent (parent/guardian); and completing active study period: enrollment through 30 days post cochlear implant surgery/activation per investigator site standard of care.
|
|---|---|
|
Age, Continuous
|
5.7 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: (SAEs) through 30 days after CI surgery/activationThe primary endpoint of the study was to demonstrate safety of the iotaSOFT Insertion System through evaluation of iotaSOFT related serious adverse events through 30 days after CI surgery/activation.
Outcome measures
| Measure |
Pediatric Cochlear Implant Recipient
n=20 Participants
Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age who meet prescribed inclusion and exclusion criteria per protocol, signing and Informed Consent and completing active study period; enrollment through 30 days post cochlear implant surgery/activation per investigator site standard of care
iotaSOFT Insertion System: robotic assistive technology for cochlear implant electrode insertion
|
|---|---|
|
iotaSOFT Related-serious Adverse Events Measured by Calculating the Proportion of Subjects With One or More SAEs.
|
0 Participants
|
Adverse Events
Pediatric Cochlear Implant Recipient
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pediatric Cochlear Implant Recipient
n=20 participants at risk
Pediatric subjects receiving a cochlear implant (iotaSOFT compatible) between the ages of 9 months and under 12 years of age; meet prescribed inclusion and exclusion criteria per protocol; signing Informed Consent (parent/guardian); and completing active study period: enrollment through 30 days post cochlear implant surgery/activation per investigator site standard of care
|
|---|---|
|
Ear and labyrinth disorders
swelling and purulent drainage from post-auricular incision
|
5.0%
1/20 • Number of events 1 • 30 days post-cochlear implant surgery/activation per investigator site standard of care.
|
Other adverse events
| Measure |
Pediatric Cochlear Implant Recipient
n=20 participants at risk
Pediatric subjects receiving a cochlear implant (iotaSOFT compatible) between the ages of 9 months and under 12 years of age; meet prescribed inclusion and exclusion criteria per protocol; signing Informed Consent (parent/guardian); and completing active study period: enrollment through 30 days post cochlear implant surgery/activation per investigator site standard of care
|
|---|---|
|
Ear and labyrinth disorders
vomiting and dizziness
|
5.0%
1/20 • Number of events 1 • 30 days post-cochlear implant surgery/activation per investigator site standard of care.
|
|
Ear and labyrinth disorders
drainage from surgical incision
|
5.0%
1/20 • Number of events 1 • 30 days post-cochlear implant surgery/activation per investigator site standard of care.
|
|
Ear and labyrinth disorders
postoperative pain
|
5.0%
1/20 • Number of events 1 • 30 days post-cochlear implant surgery/activation per investigator site standard of care.
|
|
General disorders
vomiting due to viral infection
|
5.0%
1/20 • Number of events 1 • 30 days post-cochlear implant surgery/activation per investigator site standard of care.
|
|
Infections and infestations
strep positive throat
|
10.0%
2/20 • Number of events 2 • 30 days post-cochlear implant surgery/activation per investigator site standard of care.
|
Additional Information
Laura Chenier Holbert, Director of Clinical Affairs
iotaMotion Inc.
Phone: Phone (442) 325-4171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place