TerminatedNot Applicable

Laryngeal Pacing Study

Stopped: The study was halted early as grant funding was awarded for a new study, which was opened in place of this one.

2 participantsStarted 2015-10-26

Plain-language summary

Standard treatment options for patients who are diagnosed with BVFP include tracheostomy, cordotomy, arytenoidectomy, and suture tie-back. These standard treatment options may result in permanent damage to the vocal fold, therefore affecting the patient's ability to speak and compromising airway protection during swallowing. Additionally, these routine procedures cannot provide sufficient airway to permit significant aerobic activity. The goal in conducting this early feasibility study is to investigate the use of this device as a laryngeal pacemaker to treat BVFP.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female adult patients, 22 years of age or older * Diagnosis of bilateral vocal fold paralysis, at least one year prior to study enrollment * Must have tracheostomy in place minimum of 6 weeks prior to implantation of St.Jude Medical Infinity™ IPG device * Demonstrated glottal opening bilaterally (abductory response) upon percutaneous needle stimulation of PCA muscles * Demonstrated peak inspiratory flow with respiratory testing through the mouth of at least 0.4 L/sec Exclusion Criteria: * Any active illness that is associated with an immune disorder (such as diabetes) * History of cardiac dysrhythmias or implanted cardiac pacemaker * Any electronic implanted medical device that, in the investigator's opinion, could interact with the laryngeal pacemaker * Active cardiac disease manifested by unstable angina, recent myocardial infarction, malignant arrhythmias, uncontrolled hypertension (diastolic greater than 110), or decompensated congestive heart failure * Patients with underlying comorbidities that, in the investigator's opinion, could potentially warrant a need for oxygen therapy, including but not limited to: Chronic obstructive pulmonary disease, asthma, emphysema, recurrent bronchitis, pneumonia or interstitial lung disease * Bilateral laryngeal immobility from stenosis or arthritis * Poor Surgical risk patients as determined by the treating surgeon or Vanderbilt Preoperative Evaluation Center (VPEC) * Patients with acute or chronic infe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Demonstration of a consistent surgical approach with successful implantation and functionality of a laryngeal pacemaker, as indicated by the presence of stimulated motion of the chronically paralyzed vocal fold.

Timeframe: 12 to 15 months

Trial details

NCT IDNCT03085316

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-19

View on ClinicalTrials.gov More Bilateral Vocal Fold Paralysis (BVFP) trials