Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT03790956
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03790956
Study Brief:
Protocol Section:
NCT03790956