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NCT06951594 · ClinicalTrials.gov registry record · NA
Robotic-Assisted Versus Manual Electrode Array Insertion
A NA study of Cochlear Implantation and Robotics, sponsored by University of Iowa.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06951594: Recruiting NA study of Cochlear Implantation and Robotics, sponsored by University of Iowa.
NCT06951594 is a NA study of Cochlear Implantation and Robotics that is actively recruiting participants, run by University of Iowa. The registered enrollment target is 100 participants, above the 34-participant average among 4 other Cochlear Implantation trials with a reported enrollment target (194% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06951594, a NA study of Cochlear Implantation and Robotics, is actively recruiting participants, sponsored by University of Iowa.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Whether this technical advance results in functional benefits in CI patients remains unknown. To address this critical knowledge gap, the investigators will compare cochlear trauma assessed using CT scans, cochlear and AN function assessed using ECochG and/or the eCAP, and clinical outcomes quantified by postoperative residual acoustic hearing and speech perception scores between participants randomized to either manual or robotics-assisted electrode array insertion.
Primary Outcome
Postoperative CT scan will be used to assess scalar translocation
Conditions Studied
Interventions
- DEVICE Robotic
Study Locations (1)
Iowa
- University of Iowa Healthcare - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-30 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
What NCT06951594 shows while recruiting
NCT06951594 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 34-participant average among 4 other Cochlear Implantation trials with a reported enrollment target (194% higher).
The record links to 2 conditions, with Cochlear Implantation appearing as the primary indexed condition, and to 1 intervention - of which Robotic is the first listed.
NCT06951594 reports a single indexed study location in Iowa.
Frequently Asked Questions
What is clinical trial NCT06951594 about?
NCT06951594 is a clinical study titled "Robotic-Assisted Versus Manual Electrode Array Insertion". Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control. In human cadaveric cochleae, robotics-assisted electrode insertion causes less intracochlear trauma compared to manual insertion. Wheth...
What is the current status of trial NCT06951594?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2025-06-30. Estimated completion is 2028-08-31.
What conditions does trial NCT06951594 study?
This clinical trial studies the following conditions: Cochlear Implantation, Robotics.
What interventions are being tested in trial NCT06951594?
The interventions under investigation include: Robotic (DEVICE).
Who is sponsoring clinical trial NCT06951594?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06951594 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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