Neurogenic Dysphonia/Dysphagia Registry (StrongVoice)

• ClinicalTrials.gov Identifier: NCT02493491
• Recruitment Status: Terminated
• First Posted: July 9, 2015
• Last Update Posted: September 9, 2016
• Sponsor: Merz North America, Inc.
• Collaborators: HealthCore-NERI; Cmed Clinical Services
• Information provided by (Responsible Party): Merz North America, Inc.

Tracking Information

• First Submitted Date: June 30, 2015
• First Posted Date: July 9, 2015
• Last Update Posted Date: September 9, 2016
• Study Start Date: June 2015
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 6, 2015)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 6, 2015)

• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neurogenic Dysphonia/Dysphagia Registry
• Official Title: Neurogenic Dysphonia/Dysphagia Registry
• 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.

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 [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 5 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Adults with neurogenic dysphonia/dysphagia treated with vocal fold augmentation

Condition

• Neurogenic Dysphonia
• Neurogenic Dysphagia

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 8, 2016): 146
• Original Estimated Enrollment (submitted: July 6, 2015): 400
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02493491
• Other Study ID Numbers: METIS M930901001; WI P150999
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Merz North America, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Merz North America, Inc.
• Original Study Sponsor: Same as current

Collaborators

• HealthCore-NERI
• Cmed Clinical Services

Investigators

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

• PRS Account: Merz North America, Inc.
• Verification Date: September 2016