Study Results
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View full resultsBasic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2020-09-18
2021-04-02
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
OTHER
NONE
Study Groups
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iotaSOFT Insertion System
The iotaSOFT Insertion System is a surgical device that aids the surgeon in implanting cochlear electrode arrays by controlling the speed and distance of implant insertion. All subjects enrolled in the trial will have the iotaSOFT Insertion System used during surgery.
iotaSOFT Insertion System
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.
Interventions
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iotaSOFT Insertion System
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.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
Exclusion Criteria
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray
* Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy
* Active middle ear infection
18 Years
ALL
No
Sponsors
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iotaMotion, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Gantz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa
Iowa City, Iowa, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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iotaSOFT000001
Identifier Type: -
Identifier Source: org_study_id
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