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NCT01460823 · ClinicalTrials.gov registry record · NA

Percutaneous Cochlear Implantation: Implementation of Technique

A NA study, sponsored by Vanderbilt University.

Terminated
Registry status
NA
Development phase
5
Enrollment target

NCT01460823: Clinical Trial NA study, sponsored by Vanderbilt University.

NCT01460823 is a NA study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 5 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01460823, a NA study, was terminated before completion, sponsored by Vanderbilt University.

TERMINATED
Registry status
NA
Development phase
5 participants
Enrollment target

Study Summary

The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS systems used to guide automobile travel) to drill directly from the surface of the skull to the cochlea, removing less than 2ml of bone. To use this technique, three markers (or anchor screws) are screwed into the bone around the ear. Next, an x-ray of the head (called a CT scan) is taken. Using this CT scan, a path to the inner ear (cochlea) is planned and a drill guide (Microtable) is made that mounts on the anchor screws. A drill will be attached to the guide and used to drill a path from the surface of the skull to the inner ear (cochlea). The implant electrode will be threaded through this path. All of these procedures take place under general anesthesia.

Primary Outcome

A successful percutaneous cochlear implantation is one where the facial nerve was not damaged during the procedure and the surgeon did not resort back to the standard implantation method. We will measure the percentage of participants who underwent successful cochlear implantation via the percutaneous method.

Interventions

  • PROCEDURE Percutaneous Cochlear Implantation using image guided surgical techniques

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2011-10
Est. Completion 2014-07
Phase NA
Vanderbilt University

430 total trials

Why NCT01460823 stopped before completion

NCT01460823 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Percutaneous Cochlear Implantation using image guided surgical techniques is the first listed.

NCT01460823 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01460823 about?

NCT01460823 is a clinical study titled "Percutaneous Cochlear Implantation: Implementation of Technique". The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use image-guided technology (similar to GPS systems used to guide automobil...

What is the current status of trial NCT01460823?

This trial is currently terminated. It is a NA study. The enrollment target is 5 participants. The study started on 2011-10. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01460823?

The interventions under investigation include: Percutaneous Cochlear Implantation using image guided surgical techniques (PROCEDURE).

Who is sponsoring clinical trial NCT01460823?

This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01460823's enrollment target sits among peer trials

5 1988th of 2000 higher than 5 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 NCT01460823, the US trial registry maintained by the National Library of Medicine. NCT01460823 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.