Unilateral Vocal Cord ParalysisNCT07579364
Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery
An observational study of Unilateral Vocal Cord Paralysis and Vocal Cord Atrophy, run by University of California, San Francisco at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unilateral Vocal Cord Paralysis, Vocal Cord Atrophy
- What is being tested?
- Laryngeal Framework Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 10 sitesUnited States
- Study dates
- 28 Oct 2025to Jan 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Over 18 years of age
- Diagnosed UVFP or VFA
- English speaking
- willing and able to follow up for 2 years
Who cannot join
- under 18
- non-English speaking
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Cincinnati
Cincinnati, Ohio, 45267
Ohio State University
Columbus, Ohio, 43210
University of California, San Diego
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33136
University of California, San Francisco
San Francisco, California, 94143
Washington University in St. Louis
St Louis, Missouri, 63110
Wake Forest University
Winston-Salem, North Carolina, 27101
About this study
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.
- Being tested
- Laryngeal Framework Surgery
- Keywords
- unilateral vocal fold paralysis, vocal fold atrophy, laryngeal framework surgery, arytenoid adduction, medialization thyroplasty
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Framework SurgeryProcedure or surgery
Also called medialization thyroplasty, arytenoid adduction
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 group | Role | What they receive |
|---|---|---|
| Laryngeal Framework Surgery | Participants receive Laryngeal Framework Surgery, defined as medialization thyroplasty with or without arytenoid adduction. Receives: Procedure: Laryngeal Framework Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start28 Oct 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Unilateral Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Clark Rosen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579364
- Sponsor's protocol ID
- 25-44455
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Isshiki N. Progress in laryngeal framework surgery. Acta Otolaryngol. 2000 Mar;120(2):120-7. doi: 10.1080/000164800750000748.
PubMed 11603755Menon 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 33593469Siu 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 26485674Stow 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 22075075Mes 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
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery
- ClinicalTrials.gov ID
- NCT07579364
- Acronym / sponsor ID
- 25-44455
- Keywords
- unilateral vocal fold paralysis, vocal fold atrophy, laryngeal framework surgery, arytenoid adduction, medialization thyroplasty
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- 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
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngeal Framework Surgery | – | Procedure: Laryngeal Framework SurgeryParticipants receive Laryngeal Framework Surgery, defined as medialization thyroplasty with or without arytenoid adduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Over 18 years of age
- Diagnosed UVFP or VFA
- English speaking
- willing and able to follow up for 2 years
Key exclusion criteria (2 listed)
- under 18
- non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal Framework SurgeryAlso: medialization thyroplasty, arytenoid adductionAll 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. | Procedure or surgery | Laryngeal Framework Surgery |
Primary outcome
Change from baseline in the mean VHI-10 score at 12-months post operation
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 11603755Isshiki N. Progress in laryngeal framework surgery. Acta Otolaryngol. 2000 Mar;120(2):120-7. doi: 10.1080/000164800750000748.
- Background: PubMed 33593469Menon 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.
- Background: PubMed 26485674Siu 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.
- Background: PubMed 22075075Stow 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.
- Background: PubMed 38365991Mes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clark Rosen, MD principal investigator
University of California, San Francisco
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Vocal Cord Paralysis and Vocal Cord Atrophy, run by University of California, San Francisco at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the mean VHI-10 score at 12-months post operation (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07579364, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.