Neurogenic DysphoniaStrongVoiceNCT02493491
Neurogenic Dysphonia/Dysphagia Registry
An observational study of Neurogenic Dysphonia and Neurogenic Dysphagia, run by Merz North America, Inc. at 12 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Dysphonia, Neurogenic Dysphagia
- How many people
- 146 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2015to Sep 2016
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation
Who may be able to join
- Males and Females, ≥18 years of age
- Diagnosis of neurogenic dysphonia/dysphagia
- Under active treatment with VFA and follow-up care
Who cannot join
- Patients with:
- Vocal fold scar
- Laryngeal cancer defect
- Irradiation to the larynx
- Laryngeal trauma
- End-stage cancer
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Merz Clinical Site
Augusta, Georgia, 30912
Merz Clinical Site
Boston, Massachusetts, 02115
Merz Clinical Site
Burlington, Massachusetts, 01805
Merz Clinical Site
Durham, North Carolina, 27710
Merz Clinical Site
Houston, Texas, 77030
Merz Clinical Site
La Jolla, California, 92037
Merz Clinical Site 0010334
New York, New York, 10016
Merz Clinical Site 0010068
New York, New York, 10019
Merz Clinical Site
Norfolk, Virginia, 23507
Merz Clinical Site 0010332
Pittsburgh, Pennsylvania, 15219
Merz Clinical Site
Sacramento, California, 95817
Merz Clinical Site 0010333
Sleepy Hollow, New York, 10591
About this study
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.
Read the 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
- Keywords
- dysphonia, dysphagia, neurogenic, vocal fold augmentation, VFA, vocal fold insufficiency, Prolaryn, Radiesse, Coaptite, voice, Parkinson's Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, ALS, MS, calcium hydroxylapatite, hyaluronic acid
- Medical subject headings
- Dysphonia, Deglutition Disorders, Parkinson Disease, Multiple Sclerosis, Amyotrophic Lateral Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: 5 years
Secondary outcomes (4)
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic DysphoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carelon Research, Cmed Clinical Services
- Responsible party
- Sponsor
- Investigators
- Scott Sykes, MD, Study director, Merz North America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493491
- Sponsor's protocol ID
- METIS M930901001; WI P150999
- Acronym
- StrongVoice
- Status last verified
- Sep 2016
- First submitted
- 30 Jun 2015
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurogenic Dysphonia/Dysphagia Registry
- ClinicalTrials.gov ID
- NCT02493491
- Acronym / sponsor ID
- StrongVoice / METIS M930901001; WI P150999
- Conditions
- Neurogenic Dysphonia, Neurogenic Dysphagia
- Keywords
- dysphonia, dysphagia, neurogenic, vocal fold augmentation, VFA, vocal fold insufficiency, Prolaryn, Radiesse
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Carelon Research, Cmed Clinical Services
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation
Key inclusion criteria (3 listed)
- Males and Females, ≥18 years of age
- Diagnosis of neurogenic dysphonia/dysphagia
- Under active treatment with VFA and follow-up care
Key exclusion criteria (6 listed)
- Patients with:
- Vocal fold scar
- Laryngeal cancer defect
- Irradiation to the larynx
- Laryngeal trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
4 secondary outcomes
Collect patient reported outcomes (PRO) and clinician assessments to characterize voice, swallowing, and cough outcomes post-injection
Time frame: 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
Collect and measure information on the duration of effect of Prolaryn products and the need for re-injection
Time frame: 5 years
Collect characteristics, management, and outcomes of patients who receive CaHA implants and thryoplasty
Time frame: 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Sykes, MD study director
Merz North America, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Dysphonia and Neurogenic Dysphagia, run by Merz North America, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect and characterize the different types (and frequency) of initial assessments/evaluations performed on patients. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.