Neurogenic Dysphonia/Dysphagia Registry — StrongVoice  

Neurogenic Dysphagia Clinical Trial

Official title: Neurogenic Dysphonia/Dysphagia Registry

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphonia
• Hoarseness
• Neurogenic Dysphagia
• Neurogenic Dysphonia

• NCT number: NCT02493491
• Study type: Observational [Patient Registry]
• Source: Merz Pharmaceuticals, LLC
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Completion date: September 2016