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ENROLLING BY INVITATION
NCT07579364

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

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2025-10-28

Completion Date

2028-01

Last Updated

2026-05-12

Healthy Volunteers

No

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.

Locations (10)

University of California, San Diego

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Washington University in St. Louis

St Louis, Missouri, United States

Wake Forest University

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States