CompletedNot Applicable

Silk Protein Microparticle-based Filler for Injection Augmentation

United States11 participantsStarted 2020-07-01

Plain-language summary

This study will investigate the safety and efficacy of a silk protein microparticle-based filler for vocal fold injection augmentation to treat dysphonia/dysphagia secondary to vocal fold paralysis. Participants will receive one injection and follow-up for a planned period of 12 months.

Who can participate

Age range

18 Years

Sex

ALL

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: * Unilateral vocal fold immobility with glottal insufficiency present for at least 2 weeks from onset * Willingness to partake in study and follow-up as documented by signed informed consent Exclusion Criteria: * History of allergy/hypersensitivity to silk or silk containing products * History of allergy/hypersensitivity to hyaluronic acid (HA) or HA containing products * History of allergy/hypersensitivity to lidocaine or amide-based anesthetics * History of an autoimmune condition * Significant immunocompromised state (i.e. immunosuppression s/p transplantation) * Pregnancy * Active infection or inflammation in the larynx * Comorbid known laryngeal conditions including but not limited to vocal fold scar, vocal tremor, laryngeal dystonia, etc. that would warrant other interventions for optimal treatment * History of laryngeal surgery * Life expectancy of less than 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale

Timeframe: 12 months

Trial details

NCT IDNCT03790956

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-15

View on ClinicalTrials.gov More Vocal Cord Paralysis Unilateral trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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