Neurogenic Dysphonia/Dysphagia Registry (StrongVoice)
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| ClinicalTrials.gov Identifier: NCT02493491 |
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Recruitment Status :
Terminated
First Posted : July 9, 2015
Last Update Posted : September 9, 2016
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Sponsor:
Merz North America, Inc.
Collaborators:
HealthCore-NERI
Cmed Clinical Services
Information provided by (Responsible Party):
Merz North America, Inc.
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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 |
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| Neurogenic Dysphonia Neurogenic Dysphagia |
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.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Swallowing Disorders
Primary Outcome Measures :
- 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)
- 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 :
- 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
- 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
- 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
- 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
| 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
| Study Director: | Scott Sykes, MD | Merz North America, Inc. |
Additional Information:
| 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.:
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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 |