Evaluation of efficacy and safety in bFGF injection to treat severe vocal fold lesions and vocal fold paralysis.
- Conditions
- vocal fold atrophy,vocal fold sulcus,vocal fold scars,vocal fold paralysis
- Registration Number
- JPRN-UMIN000019347
- Lead Sponsor
- Tokyo Voice Center, International University of Health and Welfare
- Brief Summary
Results: No adverse events were recorded. Significant improvements were observed in the maximum phonation time (MPT) and Voice Handicap Index (VHI) after treatment. Multiple injections achieved additional effects. Conclusions and significance: bFGF injection may be a safe and suitable office-based surgery for the alleviation of hoarseness caused by SV based on this preliminary short-term study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Not provided
The subjects with obvious decrease in cardiac function, respiratory function, or hepatic dysfunction in preoperative examinations such as blood sampling, electrocardiogram, or chest x-ray within 3 months. The subjects with vital signs such as heart rate, blood oxygen saturation, and blood pressure are abnormal on the day of surgery. The subjects with other laryngeal disease. The subjects with a history of laryngeal cancer The subjects with drug allergy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of Phonological Outcome
- Secondary Outcome Measures
Name Time Method Improvement of vocal fold vibration Improvement of Aerodynamic assessment