Neurogenic Dysphonia/Dysphagia Registry (StrongVoice)

September 8, 2016 updated by: Merz North America, Inc.
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 Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • LaJolla, California, United States, 92037
        • Merz Clinical Site
      • Sacramento, California, United States, 95817
        • Merz Clinical Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Merz Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Merz Clinical Site
      • Burlington, Massachusetts, United States, 01805
        • Merz Clinical Site
    • New York
      • New York, New York, United States, 10016
        • Merz Clinical Site 0010334
      • New York, New York, United States, 10019
        • Merz Clinical Site 0010068
      • Sleepy Hollow, New York, United States, 10591
        • Merz Clinical Site 0010333
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Merz Clinical Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • Merz Clinical Site 0010332
    • Texas
      • Houston, Texas, United States, 77030
        • Merz Clinical Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Merz Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients.
Time Frame: 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)
1 day
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
Time Frame: 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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection
Time Frame: 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
5 years
Collect types and frequency of different patient characteristics and medical care practices associated with improved health outcomes after VFA
Time Frame: 5 years
Identify patient characteristics and medical care practices associated with improved health outcomes after VFA
5 years
Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection
Time Frame: 5 years
Assess and measure the duration of effect of Prolaryn products
5 years
Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty
Time Frame: 5 years
Describe characteristics, management, and outcomes of patients who receive CaHA implants and thyroplasty
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz North America, Inc.

Collaborators

HealthCore-NERI
Cmed Clinical Services

Investigators

  • Study Director: Scott Sykes, MD, Merz North America, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

July 6, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METIS M930901001; WI P150999

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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