Neurogenic Dysphagia, Neurogenic Dysphonia
Conditions
Keywords
dysphonia, dysphagia, neurogenic, vocal fold augmentation, VFA, vocal fold insufficiency, Prolaryn, Radiesse, Coaptite, voice, Parkinson's Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, ALS, MS, calcium hydroxylapatite, hyaluronic acid
Brief summary
The Neurogenic Dysphonia/Dysphagia Registry is designed to be purely observational (i.e. non-interventional, exploratory). Patient data collected from the registry is expected to be consistent with any information which can be obtained during usual care of patients with dysphonia/dysphagia treated with vocal fold augmentation.
Detailed description
The Neurogenic Dysphonia/Dysphagia Registry is a 510K post-clearance multicenter, observational, open-label registry of the benefits and risks of management and outcomes of patients with neurogenic dysphonia/dysphagia who have received vocal fold augmentation (VFA). Enrollment is open to all eligible patients meeting all of the inclusion and none of the exclusion criteria, with a target of 400 patients. Up to 100 sites in the US and abroad will be a part of the registry. Sites will provide retrospective data for active patients who have undergone VFA within the past 24 months at the site and also begin to prospectively enroll patients who are receiving VFA as a part of their usual care. Patients will be followed for up to five years prospectively, until lost to follow-up, or death.
Interventions
None listed
Sponsors
Carelon Research
Cmed Clinical Services
Merz North America, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and Females, ≥18 years of age * Diagnosis of neurogenic dysphonia/dysphagia * Under active treatment with VFA and follow-up care
Exclusion criteria
• Patients with: * Vocal fold scar * Laryngeal cancer defect * Irradiation to the larynx * Laryngeal trauma * End-stage cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients. | 1 day | Characterize the initial assessment (e.g. types of assessments/evaluations performed and severity of voice, swallowing, cough as determined by patient reported outcomes where available) |
| Collect and characterize the different types (and frequency) of subsequent management of neurogenic dysphonia/dysphagia patients who receive VFA in terms of product used, evaluations performed and referrals and recommendations for further treatment | 5 years | Characterize subsequent management of neurogenic dysphonia/dysphagia patients who receive VFA in terms of product used, evaluations performed and referrals and recommendations for further treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection | 5 years | Characterize voice, swallowing, and cough outcomes post-injection, as determined by patient reported outcomes (PRO) and clinician assessment, as well as select adverse events/complications of interest, associated with use of VFA products in patients with neurogenic dysphonia/dysphagia, including in patients with multiple injections |
| Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA | 5 years | Identify patient characteristics and medical care practices associated with improved health outcomes after VFA |
| Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection | 5 years | Assess and measure the duration of effect of Prolaryn products |
| Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty | 5 years | Describe characteristics, management, and outcomes of patients who receive CaHA implants and thyroplasty |
Countries
United States
Outcome results
None listed