Clinical trial NCT02493491: Neurogenic Dysphonia/Dysphagia Registry
Official title: Neurogenic Dysphonia/Dysphagia Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neurogenic Dysphonia
Neurogenic Dysphagia
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
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Carelon Research
name: Cmed Clinical Services
First posted: 2015-07-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation

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.

Eligibility criteria: 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

Primary outcomes:
measure: Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients.
timeFrame: 1 day
measure: 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
timeFrame: 5 years
Secondary outcomes:
measure: Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection
timeFrame: 5 years
measure: Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA
timeFrame: 5 years
measure: Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection
timeFrame: 5 years
measure: Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty
timeFrame: 5 years
Other outcomes:
Locations:
city: LaJolla
country: United States
facility: Merz Clinical Site
state: California
city: Sacramento
country: United States
facility: Merz Clinical Site
state: California
city: Augusta
country: United States
facility: Merz Clinical Site
state: Georgia
city: Boston
country: United States
facility: Merz Clinical Site
state: Massachusetts
city: Burlington
country: United States
facility: Merz Clinical Site
state: Massachusetts
city: New York
country: United States
facility: Merz Clinical Site 0010334
state: New York
city: New York
country: United States
facility: Merz Clinical Site 0010068
state: New York
city: Sleepy Hollow
country: United States
facility: Merz Clinical Site 0010333
state: New York
city: Durham
country: United States
facility: Merz Clinical Site
state: North Carolina
city: Pittsburgh
country: United States
facility: Merz Clinical Site 0010332
state: Pennsylvania
city: Houston
country: United States
facility: Merz Clinical Site
state: Texas
city: Norfolk
country: United States
facility: Merz Clinical Site
state: Virginia
Study officials:
affiliation: Merz North America, Inc.
name: Scott Sykes, MD
role: STUDY_DIRECTOR
References: