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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07579364

Enrollment

500

Registered

2026-05-12

Start date

2025-10-28

Completion date

2028-01-01

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Vocal Cord Paralysis, Vocal Cord Atrophy

Keywords

unilateral vocal fold paralysis, vocal fold atrophy, laryngeal framework surgery, arytenoid adduction, medialization thyroplasty

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.

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* under 18 * non-English speaking

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in the mean VHI-10 score at 12-months post operation	Baseline and 12 months	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORClark Rosen, MD

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026