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Enrolling by invitationNCT07579364Updated May 12, 2026

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

An observational study in Unilateral Vocal Cord Paralysis and Vocal Cord Atrophy, sponsored by University of California, San Francisco. Enrolling by invitation at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Unilateral Vocal Cord Paralysis
  • Vocal Cord Atrophy

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Keywords

  • unilateral vocal fold paralysis
  • vocal fold atrophy
  • laryngeal framework surgery
  • arytenoid adduction
  • medialization thyroplasty
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In context

Vocal Cord Paralysis

55 studies on the registry are indexed under Vocal Cord Paralysis; 14 are open to participants now.

This study's planned enrollment of 500 is above the median of 70 across 15 observational studies indexed under Vocal Cord Paralysis.

Browse Vocal Cord Paralysis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Potential participants will be identified by treating laryngologists at the lead site (UCSF) or partner sites (Massachusetts Eye and Ear, Wake Forest, University of Cincinnati, UCSD) at the time the patient presents for their visit. If the patient is determined to have UVFP or vocal fold atrophy and is interested in undergoing surgical treatment, they will be asked about their interest in participating.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • under 18
  • non-English speaking
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Laryngeal Framework Surgery

    Participants receive Laryngeal Framework Surgery, defined as medialization thyroplasty with or without arytenoid adduction.

    Procedure: Laryngeal Framework Surgery

Interventions

  • ProcedureLaryngeal 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.

    Also known as: medialization thyroplasty, arytenoid adduction

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What researchers measure

Primary outcomes

  1. Change from baseline in the mean VHI-10 score at 12-months post operation

    Voice Handicap Index-10 is a 10-item questionnaire used to measure voice handicap. Scores range from 0-40 with higher scores indicating greater voice handicap.

    Time frame: Baseline and 12 months

07

Study locations

10 sites
  • University of California, San Diego
    La Jolla, California 92093, United States
  • University of Southern California
    Los Angeles, California 90033, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Massachusetts Eye and Ear Infirmary
    Boston, Massachusetts 02114, United States
  • Washington University in St. Louis
    St Louis, Missouri 63110, United States
  • Wake Forest University
    Winston-Salem, North Carolina 27101, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • Ohio State University
    Columbus, Ohio 43210, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
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References and documents

Publications

  • Isshiki N. Progress in laryngeal framework surgery. Acta Otolaryngol. 2000 Mar;120(2):120-7. doi: 10.1080/000164800750000748. PubMed 11603755 ↗
  • Menon JR, Mathew AS, Nath S. Arytenoid asymmetry: Is it the most predictive parameter for arytenoid adduction in unilateral vocal fold paralysis? J Laryngol Otol. 2021 Feb;135(2):159-167. doi: 10.1017/S0022215121000475. Epub 2021 Feb 17. PubMed 33593469 ↗
  • Siu J, Tam S, Fung K. A comparison of outcomes in interventions for unilateral vocal fold paralysis: A systematic review. Laryngoscope. 2016 Jul;126(7):1616-24. doi: 10.1002/lary.25739. Epub 2015 Oct 20. PubMed 26485674 ↗
  • Stow NW, Lee JW, Cole IE. Novel approach of medialization thyroplasty with arytenoid adduction performed under general anesthesia with a laryngeal mask. Otolaryngol Head Neck Surg. 2012 Feb;146(2):266-71. doi: 10.1177/0194599811427811. Epub 2011 Nov 10. PubMed 22075075 ↗
  • Mes SD, van der Jagt MA, Jansen JC, Langeveld APM, Sjogren EV, Heijnen BJ. Voice outcome in medialisation thyroplasty with and without arytenoid adduction: a prospective comparison using intraoperative voice measurements. Eur Arch Otorhinolaryngol. 2024 May;281(5):2499-2505. doi: 10.1007/s00405-024-08494-3. Epub 2024 Feb 17. PubMed 38365991 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07579364
Lead sponsor
University of California, San Francisco
Collaborators
Massachusetts Eye and Ear Infirmary, University of California, San Diego, Wake Forest University, University of Cincinnati, University of Miami, Ohio State University, Washington University School of Medicine, University of Southern California, Medical University of South Carolina
Responsible party
Sponsor
First posted
May 12, 2026
Start date
Oct 28, 2025
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
May 12, 2026

Study contacts

Clark Rosen, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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