Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-05-17
2025-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pediatric Cochlear Implant Recipient
Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age.
iotaSOFT Insertion System
robotic assistive technology for cochlear implant electrode insertion
Interventions
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iotaSOFT Insertion System
robotic assistive technology for cochlear implant electrode insertion
Eligibility Criteria
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Inclusion Criteria
* Age 9 months to less than 12 years old at the time of CI surgery
* Willingness to participate in the study and able to comply with the follow-up visit requirements
Exclusion Criteria
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion
* Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy.
* Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease
* Absence of cochlear development
* Additional medical concerns that would prevent participation in evaluations as determined by the investigator
* Planned or current participation in a clinical study of an investigational device or drug
9 Months
12 Years
ALL
Yes
Sponsors
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iotaMotion, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Chenier
Role: STUDY_DIRECTOR
iotaMotion, Inc.
Locations
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University of Iowa
Iowa City, Iowa, United States
Texas Childrens Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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iotaSOFT000002
Identifier Type: -
Identifier Source: org_study_id
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