Trial Outcomes & Findings for The iotaSOFT Insertion System Safety Study (NCT NCT04577118)

Last Updated: 2024-04-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

Day 0

Results posted on

2024-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	iotaSOFT Insertion System Purpose of this study is to evaluate safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant array.
Overall Study STARTED	25
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	iotaSOFT Insertion System Purpose of this study is to evaluate safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant array.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

4 subjects withdrawn

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iotaSOFT Insertion System n=25 Participants Overall number of baseline participants: 25 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
Age, Categorical <=18 years	0 Participants n=21 Participants • 4 subjects withdrawn
Age, Categorical Between 18 and 65 years	15 Participants n=21 Participants • 4 subjects withdrawn
Age, Categorical >=65 years	6 Participants n=21 Participants • 4 subjects withdrawn
Sex: Female, Male Female	10 Participants n=21 Participants • 4 subjects were withdrawn from the study.
Sex: Female, Male Male	11 Participants n=21 Participants • 4 subjects were withdrawn from the study.
Region of Enrollment United States	21 Participants n=21 Participants • 4 patients withdrawn

PRIMARY outcome

Timeframe: Day 0

Population: All enrolled subjects in study

Outcome measures

Outcome measures
Measure	iotaSOFT Insertion System n=21 Participants Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery	2 Participants

SECONDARY outcome

Timeframe: Day 0

Population: All subjects enrolled in the study

The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use.

Outcome measures

Outcome measures
Measure	iotaSOFT Insertion System n=21 Participants Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
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.	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: All enrolled and study completed subjects

The duration of time it takes for electrode array insertion will be measured

Outcome measures

Outcome measures
Measure	iotaSOFT Insertion System n=21 Participants Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
Procedural Duration of Time for Insertion of the Electrode Array (Mean, Range)	2.5 Minutes Interval 1.5 to 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0

Population: Enrolled and completed subjects

Post-procedural x-ray with cochlea view will be obtained to radiographically demonstrate positioning of the electrode.

Outcome measures

Outcome measures
Measure	iotaSOFT Insertion System n=21 Participants Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
Proportion of Subjects in Which the Cochlear Implant Electrode Was in the Correct Position Post-procedure	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month

Population: Enrolled and completed subjects

Potential risks and benefits of iotaSOFT will be assessed and characterized through data obtained during the post-surgical follow-up period while conducting impedance measurements and neural response telemetry.

Outcome measures

Outcome measures
Measure	iotaSOFT Insertion System n=21 Participants Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
Adverse Events Reported During the Follow-up Period as Documented by Impedance and Neural Response Telemetry Testing. Adverse Events Will be Categorized by Type and Number of Participants Experiencing an Event.	0 Participants

Adverse Events

iotaSOFT Insertion System

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	iotaSOFT Insertion System n=21 participants at risk Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
Psychiatric disorders Altered mental state	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Surgical and medical procedures Patient hospitalization following knee surgery	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.

Other adverse events

Other adverse events
Measure	iotaSOFT Insertion System n=21 participants at risk Overall number of baseline participants: 21 Candidacy: Based on FDA indication for cochlear implantation Age: 18 years and older Language: English
Ear and labyrinth disorders Resistance with iotaSOFT	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders No stimulation with device	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders Drainage at implant site	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders Bruising and dizziness	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders CSF Leak	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders Dizziness	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders Incision coming open at CI site as seen at 2-week post-op visit.	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders Tinnitus	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders Pain at incision	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Eye disorders Swelling of face and eye area	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.
Ear and labyrinth disorders Facial Stim	4.8% 1/21 • Number of events 1 • Surgery to 1 month post-operative Device related AEs and general AEs collected.

Additional Information

Laura Chenier

iotaMotion, Inc

Phone: 442-325-4171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place