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NCT03101917 · ClinicalTrials.gov registry record · NA

Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)

A NA study, sponsored by Medical University of South Carolina.

Not yet
Registry status
NA
Development phase
12
Enrollment target

NCT03101917: Clinical Trial NA study, sponsored by Medical University of South Carolina.

NCT03101917 is a NA study that has not yet begun recruiting, run by Medical University of South Carolina. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03101917, a NA study, has not yet begun recruiting, sponsored by Medical University of South Carolina.

NOT YET RECRUITING
Registry status
NA
Development phase
12 participants
Enrollment target

Study Summary

The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less invasive surgical option than currently performed. Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize that the minimally invasive, image-guided approach may offer the following benefits: (1) shorter procedure time including shorter general anesthesia time, (2) less tissue removal potentially eliminating post-operative mastoid bone depression, decreased post-operative patient discomfort, and quicker wound healing, (3) better chance of preservation of taste secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode placement potentially allowing more consistent placement within the scala tympani sub-compartment of the cochlea which has been shown to be associated with improved post-operative audiological performance. This early feasibility study will focus on the advantages of the new technology to the patient. Advantages to the healthcare delivery system will be examined during the pivotal study phase.

Primary Outcome

Assessed by CT confirmation of intra-cochlear placement of the electrode array.

Interventions

  • DEVICE The Microtable® Stereotactic System

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2027-07-01
Est. Completion 2028-07-31
Phase NA

What is known before NCT03101917 opens enrollment

NCT03101917 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which The Microtable® Stereotactic System is the first listed.

NCT03101917 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03101917 about?

NCT03101917 is a clinical study titled "Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)". The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing pla...

What is the current status of trial NCT03101917?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2027-07-01. Estimated completion is 2028-07-31.

What interventions are being tested in trial NCT03101917?

The interventions under investigation include: The Microtable® Stereotactic System (DEVICE).

Who is sponsoring clinical trial NCT03101917?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03101917's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 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 NCT03101917, the US trial registry maintained by the National Library of Medicine. NCT03101917 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.