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Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery

NCT07579364 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-05-12

No results posted yet for this study

Summary

The goal of this observational study is to learn about the long-term outcomes of Laryngeal Framework Surgery (LFS) in patients with Unilateral Vocal Fold Paralysis (UVFP) or Vocal Fold Atrophy (VFA). The main questions it aims to answer are:

* Whether LFS technique (implant material, addition of arytenoid adduction) is associated with differences in outcomes such as complication rate, duration of surgery, hospital stay length, and quality of voice post-surgery.
* Whether UVFP or VFA diagnosis is associated with differences in outcomes such as complication rate, duration of surgery, hospital stay length, and quality of voice post-surgery.

Participants who are determined by their clinician to need LFS for their UVFP or VFA will undergo the procedure, attend follow-up appointments, and complete surveys about their voice and swallowing ability as they would as part of their regular medical care.

Conditions

  • Unilateral Vocal Cord Paralysis
  • Vocal Cord Atrophy

Interventions

PROCEDURE

Laryngeal Framework Surgery

All participants will receive laryngeal framework surgery as recommended by their treating surgeon. This can include medialization thyroplasty with or without arytenoid adduction, under general anesthesia or monitored anesthesia care.

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    collaborator OTHER

  • University of California, San Diego

    collaborator OTHER

  • Wake Forest University

    collaborator OTHER

  • University of Cincinnati

    collaborator OTHER

  • University of Miami

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • University of Southern California

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Clark Rosen, MD · University of California, San Francisco

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07579364 on ClinicalTrials.gov