RecruitingNot Applicable

Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

United States15 participantsStarted 2019-12-10

Plain-language summary

This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.

Who can participate

Age range

18 Years – 70 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: * Patients aged 18-70 * Patients with bilateral vocal fold paralysis without any improvement for 6 months Exclusion Criteria: * Patients with neck or chest radiation * Patients with severe respiratory compromise * Patients with cricoarytenoid ankylosis * Patients with pacemakers * Patients who are pregnant * Patients with cochlear implant, or any nerve stimulator implants

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

Change in breathing function is being assessed and measured by the Dyspnea Index (DI)

Timeframe: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months

Change in breathing function is being assessed and measured by pulmonary function testing

Timeframe: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months

Trial details

NCT IDNCT03980275

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-12-31

Contact for this trial

Babak Sadoughi, MD

646-962-4712 bas9049@med.cornell.edu

View on ClinicalTrials.gov More Bilateral Vocal Cord Paralysis trials

Who can participate

Age range

18 Years – 70 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.

What they're measuring

Change in breathing function is being assessed and measured by the Dyspnea Index (DI)

Timeframe: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months

Change in breathing function is being assessed and measured by pulmonary function testing

Timeframe: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months