Study Purpose:
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.Study Status:
Not recruiting
Disease:
Neurogenic Dysphonia , Neurogenic Dysphagia
Study Type:
Observational [Patient Registry]
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Scott Sykes, MD, Merz North America, Inc.
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
United States
Full Study Summary:
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 Sponsor:
Merz North America, Inc.
Estimated Enrollment:
146
Estimated Study Start Date:
05 / 31 / 2015
Estimated Study Completion Date:
09 / 01 / 2016
Posting Last Modified Date:
09 / 09 / 2016
Date Study Added to neals.org:
07 / 09 / 2015
This study has been terminated. For more information, visit: https://clinicalt...CT02493491&rank=1
Minimum Age:
18 Years
Maximum Age:
N/A
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
Merz Clinical Site
LaJolla, California
92037
United States
Merz Clinical Site
Sacramento, California
95817
United States
Merz Clinical Site
Augusta, Georgia
30912
United States
Merz Clinical Site
Boston, Massachusetts
02115
United States
Merz Clinical Site
Burlington, Massachusetts
01805
United States
Merz Clinical Site 0010334
New York, New York
10016
United States
Merz Clinical Site 0010068
New York, New York
10019
United States
Merz Clinical Site 0010333
Sleepy Hollow, New York
10591
United States
Merz Clinical Site
Durham, North Carolina
27710
United States
Merz Clinical Site 0010332
Pittsburgh, Pennsylvania
15219
United States
Merz Clinical Site
Houston, Texas
77030
United States
Merz Clinical Site
Norfolk, Virginia
23507
United States