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Clinical Trials/NCT07579364
NCT07579364Enrolling By InvitationNot Applicable

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

University of California, San Francisco10 sites in 1 country500 target enrollmentStarted: October 28, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
500
Locations
10
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Over 18 years of age
  • •Diagnosed UVFP or VFA
  • •English speaking
  • •willing and able to follow up for 2 years

Exclusion Criteria

  • •non-English speaking

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (10)

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