NCT02493491

Neurogenic Dysphonia/Dysphagia Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 146 (actual)
• Sponsor: Merz North America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Neurogenic Dysphonia
• Neurogenic Dysphagia

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2015-07-09
• Last updated: 2016-09-09

Locations

12 sites across 1 country: United States