Neurogenic Dysphonia/Dysphagia Registry

NCT02493491 | Terminated DMC

• 1 other identifier: METIS M930901001; WI P150999
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection

  5 years

• Collect types and frequency of different 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

  5 years

• Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation

You may qualify if:

• Males and Females, ≥18 years of age
• Diagnosis of neurogenic dysphonia/dysphagia
• Under active treatment with VFA and follow-up care

You may not qualify if:

• Patients with:
• Vocal fold scar
• Laryngeal cancer defect
• Irradiation to the larynx
• Laryngeal trauma
• End-stage cancer

Sponsors & Collaborators

• Merz North America, Inc.: lead
• Carelon Research: collaborator
• Cmed Clinical Services: collaborator

Study Sites (12)

Merz Clinical Site

La Jolla, California, 92037, United States

Location

Merz Clinical Site

Sacramento, California, 95817, United States

Location

Merz Clinical Site

Augusta, Georgia, 30912, United States

Location

Merz Clinical Site

Boston, Massachusetts, 02115, United States

Location

Merz Clinical Site

Burlington, Massachusetts, 01805, United States

Location

Merz Clinical Site 0010334

New York, New York, 10016, United States

Location

Merz Clinical Site 0010068

New York, New York, 10019, United States

Location

Merz Clinical Site 0010333

Sleepy Hollow, New York, 10591, United States

Location

Merz Clinical Site

Durham, North Carolina, 27710, United States

Location

Merz Clinical Site 0010332

Pittsburgh, Pennsylvania, 15219, United States

Location

Merz Clinical Site

Houston, Texas, 77030, United States

Location

Merz Clinical Site

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Dysphonia; Deglutition Disorders; Parkinson Disease; Multiple Sclerosis; Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Scott Sykes, MD

  Merz North America, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 9, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

US (12)