FindMyKOL
Clinical trialNCT00064571TerminatedPhase 3Interventional

Surgery for Vocal Cord Paralysis

SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)Enrollment300Unilateral Vocal Cord Paralysis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Unilateral vocal fold paralysis (UVFP) is caused by injury to the nerve to the affected vocal fold. The injury to the vocal fold makes the affected person's voice sound "breathy". Voice therapy is usually tried first, and, if unsuccessful, surgical treatment is considered. The standard surgical treatment is called vocal fold medialization and aims to bring the injured cord to the midline. An alternative surgical treatment, vocal fold reinnervation, aims to bring a new nerve supply to the injured vocal fold. The reinnervation operation, which has some potential advantages over the medialization operation also requires several months for final results to be gained. The goal of this multicenter, randomized clinical trial is to see which of the two surgical treatments produces a better outcome. In order to participate in this study patients with UVFP must meet all entry criteria and must be released from voice therapy by a speech-language pathologist. Information collected for the study (pre-surgery, and at 6 and 12 months after surgery) includes voice recordings, movies made of vocal fold function, airflow and pressure measurements of the voicebox, and an outcomes questionnaire.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama-Birmingham

    Birmingham, Alabama, United States

  • Uc-Irvine Medical Center

    Irvine, California, United States

  • George Washington University

    Washington D.C., District of Columbia, United States

  • University of Minnesota

    Minneapolis, Minnesota, United States

  • Washington University

    St Louis, Missouri, United States

  • University of Cincinnati

    Cincinnati, Ohio, United States

  • Cleveland Clinic

    Cleveland, Ohio, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

  • University of Utah

    Salt Lake City, Utah, United States

  • University of Wisconsin

    Madison, Wisconsin, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Oct 2002
Primary completion
—
Completion
31 Oct 2005
Last update posted
24 Apr 2006
Registered enrollment
300
Registry id
NCT00064571

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.