Neurogenic Dysphonia/Dysphagia Registry

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:

NCT02493491

Neals Affiliated?

No

Coordinating Center Contact Information

United States

Full Study Summary:

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 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