Neurogenic Dysphonia/Dysphagia Registry
- Conditions
- Neurogenic DysphoniaNeurogenic Dysphagia
- Registration Number
- NCT02493491
- Lead Sponsor
- Merz North America, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 146
- Males and Females, ≥18 years of age
- Diagnosis of neurogenic dysphonia/dysphagia
- Under active treatment with VFA and follow-up care
• Patients with:
- Vocal fold scar
- Laryngeal cancer defect
- Irradiation to the larynx
- Laryngeal trauma
- End-stage cancer
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
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 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
Trial Locations
- Locations (5)
Merz Clinical Site 0010334
🇺🇸New York, New York, United States
Merz Clinical Site
🇺🇸Norfolk, Virginia, United States
Merz Clinical Site 0010068
🇺🇸New York, New York, United States
Merz Clinical Site 0010333
🇺🇸Sleepy Hollow, New York, United States
Merz Clinical Site 0010332
🇺🇸Pittsburgh, Pennsylvania, United States