None listed
Conditions
Interventions
Medical Device : The vocal fold injection procedure for subjects enrolled is standardized and conducted by a single laryngologist. After the subject is fixed to a sitting position with the neck extend
Medytox Inc., Cheongju-si, Republic of Korea) is used as the injectate for vocal fold augmentation.
Number of injection (intervention) : once
Follow up of patient after injection (intervention) : 1
Sponsors
Seoul National University Bundang Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age 19 – 85 years old with unilateral vocal fold paralysis subjects indicated for treatment with vocal fold injection therapy
Exclusion criteria
Exclusion criteria: 1) Patients with hyper-reactivity with hyaluronic acid 2) bilateral vocal fold paralysis 3) Subjects with previous history of malignancy in head and neck region 4) Subjects with history of radiation to head and neck region 5) Subjects with previous history of laryngeal framework surgery 6) Subjects with history of stenotic lesion of larynx, tracheal or other upper airway region 7) Pregnancy or Breastfeeding state 8) Anticipated for pregnancy 9) Subjects that have participated with other clinical trial in 30 days prior to this study 10) Other specific reasons considered to be inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| voice handicapped index (VHI-10), GRBAS dysphonia scale, aerodynamic study, and multi-dimensional voice program | — |
Secondary
| Measure | Time frame |
|---|---|
| duration of procedure ;acute or delayed adverse events of real-time light-guided vocal fold injection | — |
Countries
Korea, Republic of
Contacts
Public ContactGene Huh
Seoul National University Hospital
Outcome results
None listed