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NCT04577118 · ClinicalTrials.gov registry record · NA

The iotaSOFT Insertion System Safety Study

A NA study, sponsored by iotaMotion.

Completed
Registry status
NA
Development phase
25
Enrollment target

NCT04577118: Completed NA study, sponsored by iotaMotion.

NCT04577118 is a NA study that has completed, run by iotaMotion. The registered enrollment target is 25 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.

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The verdict

NCT04577118, a NA study, has completed, sponsored by iotaMotion.

COMPLETED
Registry status
NA
Development phase
25 participants
Enrollment target

Study Summary

Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

Primary Outcome

Number of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event.

Interventions

  • DEVICE iotaSOFT Insertion System

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2020-09-18
Est. Completion 2021-04-02
Phase NA
iotaMotion

4 total trials

What the finished NCT04577118 record still lists

NCT04577118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 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 1 intervention - of which iotaSOFT Insertion System is the first listed.

NCT04577118 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04577118 about?

NCT04577118 is a clinical study titled "The iotaSOFT Insertion System Safety Study". Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

What is the current status of trial NCT04577118?

This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2020-09-18. Estimated completion is 2021-04-02.

What interventions are being tested in trial NCT04577118?

The interventions under investigation include: iotaSOFT Insertion System (DEVICE).

Who is sponsoring clinical trial NCT04577118?

This trial is sponsored by iotaMotion, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04577118's enrollment target sits among peer trials

25 1712th of 2000 higher than 265 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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Source: ClinicalTrials.gov NCT04577118, the US trial registry maintained by the National Library of Medicine. NCT04577118 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.