Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
146 participants
OBSERVATIONAL
2015-06-30
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of neurogenic dysphonia/dysphagia
* Under active treatment with VFA and follow-up care
Exclusion Criteria
* Vocal fold scar
* Laryngeal cancer defect
* Irradiation to the larynx
* Laryngeal trauma
* End-stage cancer
18 Years
ALL
No
Sponsors
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Carelon Research
OTHER
Cmed Clinical Services
OTHER
Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Sykes, MD
Role: STUDY_DIRECTOR
Merz North America, Inc.
Locations
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Merz Clinical Site
La Jolla, California, United States
Merz Clinical Site
Sacramento, California, United States
Merz Clinical Site
Augusta, Georgia, United States
Merz Clinical Site
Boston, Massachusetts, United States
Merz Clinical Site
Burlington, Massachusetts, United States
Merz Clinical Site 0010334
New York, New York, 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
Durham, North Carolina, United States
Merz Clinical Site 0010332
Pittsburgh, Pennsylvania, United States
Merz Clinical Site
Houston, Texas, United States
Merz Clinical Site
Norfolk, Virginia, United States
Countries
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Other Identifiers
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METIS M930901001; WI P150999
Identifier Type: -
Identifier Source: org_study_id
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