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NCT04028674 · ClinicalTrials.gov registry record · NA

Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx

A NA study of Bilateral Vocal Fold Paralysis (BVFP), sponsored by Vanderbilt University Medical Center.

Active
Registry status
NA
Development phase
8
Enrollment target
1
Study location

NCT04028674: Active NA study of Bilateral Vocal Fold Paralysis (BVFP), sponsored by Vanderbilt University Medical Center.

NCT04028674 is a NA study of Bilateral Vocal Fold Paralysis (BVFP) that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04028674, a NA study of Bilateral Vocal Fold Paralysis (BVFP), is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

The primary purpose of this project is to evaluate the safety of new treatment termed bilateral laryngeal pacing to improve treatment outcomes in patients with bilateral vocal fold paralysis (BVFP) (Aim 1). Outcome measures related to voice and ventilation will also provide initial insights into the efficacy of bilateral (Aim 2) and unilateral (Aim 3) stimulation of the implanted device to improve treatment outcomes in patients with BVFP.

Interventions

  • DEVICE Laryngeal Pacing Device

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2021-01-14
Est. Completion 2028-12
Phase NA

What the registry record for NCT04028674 still lists

NCT04028674 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 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 1 condition, with Bilateral Vocal Fold Paralysis (BVFP) appearing as the primary indexed condition, and to 1 intervention - of which Laryngeal Pacing Device is the first listed.

NCT04028674 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT04028674 about?

NCT04028674 is a clinical study titled "Functional Electrical Stimulation of the Bilaterally Paralyzed Human Larynx". The primary purpose of this project is to evaluate the safety of new treatment termed bilateral laryngeal pacing to improve treatment outcomes in patients with bilateral vocal fold paralysis (BVFP) (Aim 1). Outcome measures related to voice and ventilation will also provide initial insights into the...

What is the current status of trial NCT04028674?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 8 participants. The study started on 2021-01-14. Estimated completion is 2028-12.

What conditions does trial NCT04028674 study?

This clinical trial studies the following conditions: Bilateral Vocal Fold Paralysis (BVFP).

What interventions are being tested in trial NCT04028674?

The interventions under investigation include: Laryngeal Pacing Device (DEVICE).

Who is sponsoring clinical trial NCT04028674?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04028674 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04028674's enrollment target sits among peer trials

8 1976th of 2000 higher than 19 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 NCT04028674, the US trial registry maintained by the National Library of Medicine. NCT04028674 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.