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NCT07081542 · ClinicalTrials.gov registry record · NA
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
A NA study, sponsored by AdventHealth.
- Not yet
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT07081542 is a NA study that has not yet begun recruiting, run by AdventHealth. The registered enrollment target is 32 participants.
The verdict
NCT07081542, a NA study, has not yet begun recruiting, sponsored by AdventHealth.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use. The main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care. This study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.
Interventions
- DEVICE IotaSoft Robotic Insertion System
- PROCEDURE Manual Cochlear Implant Insertion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2026-01-01 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07081542
The ClinicalTrials.gov registry entry for NCT07081542 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AdventHealth, which has 95 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IotaSoft Robotic Insertion System is the first listed.
NCT07081542 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07081542 about?
NCT07081542 is a clinical study titled "Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants". This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of th...
What is the current status of trial NCT07081542?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 32 participants. The study started on 2026-01-01. Estimated completion is 2027-01-31.
What interventions are being tested in trial NCT07081542?
The interventions under investigation include: IotaSoft Robotic Insertion System (DEVICE), Manual Cochlear Implant Insertion (PROCEDURE).
Who is sponsoring clinical trial NCT07081542?
This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.
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