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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Francisco
Study ID
NCT07579364
Status
Enrolling By Invitation

Conditions

  • Unilateral Vocal Cord Paralysis
  • Vocal Cord Atrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laryngeal Framework Surgery — PROCEDURE
    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 Details

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 Dates

Start date
Oct 28, 2025
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

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

Primary Outcome Measure

Change from baseline in the mean VHI-10 score at 12-months post operation [ Time Frame: Baseline and 12 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093-
University of Southern CaliforniaLos AngelesCalifornia90033-
University of California, San FranciscoSan FranciscoCalifornia94143-
University of MiamiMiamiFlorida33136-
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114-
Washington University in St. LouisSt LouisMissouri63110-
Wake Forest UniversityWinston-SalemNorth Carolina27101-
University of CincinnatiCincinnatiOhio45267-
Ohio State UniversityColumbusOhio43210-
Medical University of South CarolinaCharlestonSouth Carolina29425-

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