Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Carelon Research | OTHER |
| Cmed Clinical Services | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients. | 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) | 1 day |
| 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 | 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 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Patients with:
Not provided
Not provided
Not provided
Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Sykes, MD | Merz North America, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Clinical Site | La Jolla | California | 92037 | United States | ||
| Merz Clinical Site |
Not provided
| ID | Term |
|---|---|
| D055154 | Dysphonia |
| D003680 | Deglutition Disorders |
| D010300 | Parkinson Disease |
| D009103 | Multiple Sclerosis |
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 years |
| Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA | Identify patient characteristics and medical care practices associated with improved health outcomes after VFA | 5 years |
| Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection | Assess and measure the duration of effect of Prolaryn products | 5 years |
| Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty | Describe characteristics, management, and outcomes of patients who receive CaHA implants and thyroplasty | 5 years |
| Sacramento |
| California |
| 95817 |
| United States |
| Merz Clinical Site | Augusta | Georgia | 30912 | United States |
| Merz Clinical Site | Boston | Massachusetts | 02115 | United States |
| Merz Clinical Site | Burlington | Massachusetts | 01805 | United States |
| Merz Clinical Site 0010334 | New York | New York | 10016 | United States |
| Merz Clinical Site 0010068 | New York | New York | 10019 | United States |
| Merz Clinical Site 0010333 | Sleepy Hollow | New York | 10591 | United States |
| Merz Clinical Site | Durham | North Carolina | 27710 | United States |
| Merz Clinical Site 0010332 | Pittsburgh | Pennsylvania | 15219 | United States |
| Merz Clinical Site | Houston | Texas | 77030 | United States |
| Merz Clinical Site | Norfolk | Virginia | 23507 | United States |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013118 | Spinal Cord Diseases |
| D016472 | Motor Neuron Disease |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |