anofat: a novel therapeutic approach for vocal cord scar

Not Applicable

• Conditions: Vocal cord insufficiency; vocal cord scar; Surgery - Surgical techniques; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12620000450910
• Lead Sponsor: Department of Otolaryngology, Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

vocal cord scar

Exclusion Criteria

evidence of other vocal fold abnormalities (granuloma, polyps, sulcus or other pathology affecting vocal fold vibration), previous history of glottic cancer, previous laser resection of the vocal fold, prior radiotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported voice-related quality of life measures <br>(VoiSS and perceived overall voice impairment on VAS)[3, 6, and 12 months (primary timepoint) post-injection<br>]

Secondary Outcome Measures

Name	Time	Method
Vibratory properties measured on stroboscopy by a blinded, trained , independent rater [pre-procedure<br>post-procedure at 1 week, 3 months, 6 months, 12 months ];Harmonic: noise ratio measured on Phontary Aerodynamic System Measurement tool[pre-procedure, <br>3, 6, and 12 months from intervention];phonation threshold pressure measured on Phontary Aerodynamic System Measurement tool[Pre-procedure <br>3, 6, and 12 months post-procedure ];Subglottic pressure measured on Phontary Aerodynamic System Measurement tool[Pre-procedure <br>3, 6, and 12 months post-procedure ];Perturbation measured on stroboscopy [Pre-procedure <br>3, 6, and 12 months post-procedure ];fundamental frequency measured on stroboscopy[Pre-procedure <br>3, 6, and 12 months post-procedure ]; intensity measured on stroboscopy[Pre-procedure <br>3, 6, and 12 months post-procedure ]; s:z ratio measured on stroboscopy[Pre-procedure <br>3, 6, and 12 months post-procedure ]