StrongVoice: Neurogenic Dysphonia/Dysphagia Registry

Sponsor

Merz North America, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02493491

Collaborator

HealthCore-NERI (Other), Cmed Clinical Services (Other)

146

Enrollment

Locations

Duration (Months)

12.2

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Dysphonia Neurogenic Dysphagia

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

146 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Neurogenic Dysphonia/Dysphagia Registry

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Sep 1, 2016

Outcome Measures

Primary Outcome Measures

Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients. [1 day]
Characterize the initial assessment (e.g. types of assessments/evaluations performed and severity of voice, swallowing, cough as determined by patient reported outcomes where available)
Collect and characterize the different types (and frequency) of subsequent management of neurogenic dysphonia/dysphagia patients who receive VFA in terms of product used, evaluations performed and referrals and recommendations for further treatment [5 years]
Characterize subsequent management of neurogenic dysphonia/dysphagia patients who receive VFA in terms of product used, evaluations performed and referrals and recommendations for further treatment

Secondary Outcome Measures

Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection [5 years]
Characterize voice, swallowing, and cough outcomes post-injection, as determined by patient reported outcomes (PRO) and clinician assessment, as well as select adverse events/complications of interest, associated with use of VFA products in patients with neurogenic dysphonia/dysphagia, including in patients with multiple injections
Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA [5 years]
Identify patient characteristics and medical care practices associated with improved health outcomes after VFA
Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection [5 years]
Assess and measure the duration of effect of Prolaryn products
Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty [5 years]
Describe characteristics, management, and outcomes of patients who receive CaHA implants and thyroplasty

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merz Clinical Site	LaJolla	California	United States	92037
2	Merz Clinical Site	Sacramento	California	United States	95817
3	Merz Clinical Site	Augusta	Georgia	United States	30912
4	Merz Clinical Site	Boston	Massachusetts	United States	02115
5	Merz Clinical Site	Burlington	Massachusetts	United States	01805
6	Merz Clinical Site 0010334	New York	New York	United States	10016
7	Merz Clinical Site 0010068	New York	New York	United States	10019
8	Merz Clinical Site 0010333	Sleepy Hollow	New York	United States	10591
9	Merz Clinical Site	Durham	North Carolina	United States	27710
10	Merz Clinical Site 0010332	Pittsburgh	Pennsylvania	United States	15219
11	Merz Clinical Site	Houston	Texas	United States	77030
12	Merz Clinical Site	Norfolk	Virginia	United States	23507