CompletedPhase 4

Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis

Indonesia19 participantsStarted 2018-01-01

Plain-language summary

The study tries to see the effect of using a combination of platelet-rich fibrin (PRF) and autologous fat as a filler for injection laryngoplasty procedures to treat unilateral adductor vocal cord paralysis.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is diagnosed with unilateral vocal cord paralysis in paramedian position or 3 months lateral onset without movement and mucosal waves of the vocal cords on videostroboscopy. * Willing to give consent Exclusion Criteria: * Has a history of malignancy of the larynx or lung * Subject isn't able to undergo injection laryngoplasty procedure under general anesthesia * Subject with thrombositopenia

What they're measuring

Change in Voice Handicap Index-30 (VHI-30) questionnaire score

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Maximum Phonation Time

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Average Fundamental Frequency (F0)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Jitter and Shimmer

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Noise to Harmonic Ratio (NHR)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Voice Turbulence Index (VTI)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Amplitude Tremor Intensity Index (ATRI)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Vocal Cord Closure Pattern

Trial details

NCT IDNCT04839276

SponsorFakultas Kedokteran Universitas Indonesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06-01

View on ClinicalTrials.gov More Vocal Cord Paralysis trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Voice Handicap Index-30 (VHI-30) questionnaire score

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Maximum Phonation Time

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Average Fundamental Frequency (F0)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Jitter and Shimmer

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Noise to Harmonic Ratio (NHR)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Voice Turbulence Index (VTI)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Amplitude Tremor Intensity Index (ATRI)

Timeframe: Before injection, 1 week, 4 week, 8 week post-injection

Changes in Vocal Cord Closure Pattern