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NCT00064571 · ClinicalTrials.gov registry record · Phase 3
Surgery for Vocal Cord Paralysis
A Phase 3 study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- Terminated
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
NCT00064571 is a Phase 3 study that was terminated before completion, run by National Institute on Deafness and Other Communication Disorders (NIDCD). The registered enrollment target is 300 participants.
The verdict
NCT00064571, a Phase 3 study, was terminated before completion, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE vocal fold medialization
- PROCEDURE vocal fold reinnervation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2002-10 |
| Est. Completion | 2005-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00064571
The ClinicalTrials.gov registry entry for NCT00064571 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which vocal fold medialization is the first listed.
NCT00064571 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00064571 about?
NCT00064571 is a clinical study titled "Surgery for Vocal Cord Paralysis". 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 trea...
What is the current status of trial NCT00064571?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2002-10. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00064571?
The interventions under investigation include: vocal fold medialization (PROCEDURE), vocal fold reinnervation (PROCEDURE).
Who is sponsoring clinical trial NCT00064571?
This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total clinical trials registered on ClinicalTrials.gov.
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