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Trial record 1 of 1 for:    NCT02493491
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Neurogenic Dysphonia/Dysphagia Registry (StrongVoice)

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ClinicalTrials.gov Identifier: NCT02493491
Recruitment Status : Terminated
First Posted : July 9, 2015
Last Update Posted : September 9, 2016
Sponsor:
Collaborators:
HealthCore-NERI
Cmed Clinical Services
Information provided by (Responsible Party):
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.

Condition or disease
Neurogenic Dysphonia Neurogenic Dysphagia

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Neurogenic Dysphonia/Dysphagia Registry
Study Start Date : June 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016





Primary Outcome Measures :
  1. Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients. [ Time Frame: 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)

  2. 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 [ Time Frame: 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 :
  1. Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection [ Time Frame: 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

  2. Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA [ Time Frame: 5 years ]
    Identify patient characteristics and medical care practices associated with improved health outcomes after VFA

  3. Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection [ Time Frame: 5 years ]
    Assess and measure the duration of effect of Prolaryn products

  4. Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty [ Time Frame: 5 years ]
    Describe characteristics, management, and outcomes of patients who receive CaHA implants and thyroplasty



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493491


Locations
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United States, California
Merz Clinical Site
LaJolla, California, United States, 92037
Merz Clinical Site
Sacramento, California, United States, 95817
United States, Georgia
Merz Clinical Site
Augusta, Georgia, United States, 30912
United States, Massachusetts
Merz Clinical Site
Boston, Massachusetts, United States, 02115
Merz Clinical Site
Burlington, Massachusetts, United States, 01805
United States, New York
Merz Clinical Site 0010334
New York, New York, United States, 10016
Merz Clinical Site 0010068
New York, New York, United States, 10019
Merz Clinical Site 0010333
Sleepy Hollow, New York, United States, 10591
United States, North Carolina
Merz Clinical Site
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Merz Clinical Site 0010332
Pittsburgh, Pennsylvania, United States, 15219
United States, Texas
Merz Clinical Site
Houston, Texas, United States, 77030
United States, Virginia
Merz Clinical Site
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Merz North America, Inc.
HealthCore-NERI
Cmed Clinical Services
Investigators
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Study Director: Scott Sykes, MD Merz North America, Inc.
Additional Information:

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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT02493491    
Other Study ID Numbers: METIS M930901001; WI P150999
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Keywords provided by Merz North America, Inc.:
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
Additional relevant MeSH terms:
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Deglutition Disorders
Dysphonia
Hoarseness
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory