Neurogenic Dysphonia/Dysphagia Registry

Neurogenic Dysphagia Clinical Trial

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Official title:

Neurogenic Dysphonia/Dysphagia Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02493491
• Other study ID #: METIS M930901001; WI P150999
• Status: Terminated
• Phase: N/A
• First received: June 30, 2015
• Last updated: September 8, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 146
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Merz Clinical Site	Augusta	Georgia
United States	Merz Clinical Site	Boston	Massachusetts
United States	Merz Clinical Site	Burlington	Massachusetts
United States	Merz Clinical Site	Durham	North Carolina
United States	Merz Clinical Site	Houston	Texas
United States	Merz Clinical Site	LaJolla	California
United States	Merz Clinical Site 0010068	New York	New York
United States	Merz Clinical Site 0010334	New York	New York
United States	Merz Clinical Site	Norfolk	Virginia
United States	Merz Clinical Site 0010332	Pittsburgh	Pennsylvania
United States	Merz Clinical Site	Sacramento	California
United States	Merz Clinical Site 0010333	Sleepy Hollow	New York

Sponsors (3)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC	Cmed Clinical Services, New England Research Institutes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients.	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)	1 day	No
Primary	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	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	5 years	No
Secondary	Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection	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	5 years	No
Secondary	Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA	Identify patient characteristics and medical care practices associated with improved health outcomes after VFA	5 years	No
Secondary	Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection	Assess and measure the duration of effect of Prolaryn products	5 years	No
Secondary	Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty	Describe characteristics, management, and outcomes of patients who receive CaHA implants and thyroplasty	5 years	No