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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: Clinical Trial NA study, sponsored by AdventHealth.
NCT07081542 is a NA study that has not yet begun recruiting, run by AdventHealth. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in unaided pure tone thresholds at 125, 250, and 500 Hz from baseline to 12 months post-activation. The average of these frequencies will be computed for each participant.
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 |
What is known before NCT07081542 opens enrollment
NCT07081542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which IotaSoft Robotic Insertion System is the first listed.
NCT07081542 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07081542's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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