Vocal Cord ParalysisNCT00845442
Dynamic Laryngeal Opening for Bilateral Vocal Fold Paralysis by an Implanted Stimulator
A study testing pacemaker in people with Vocal Cord Paralysis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vocal Cord Paralysis
- What is being tested?
- pacemaker
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2006to 1 Nov 2010
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breathing difficulties from vocal cord paralyses
- Tracheostomy tube
- Ability to understand the purpose of the research
- Appropriate hand motor coordination
Who cannot join
- Lack of understanding the research
- Poor hand motor coordination
- Non-acceptance of tracheostomy
- Inability to passively move the paralyzed vocal cords
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Dynamic Vocal Fold Abduction for Bilateral Paralysis
People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.
Read the detailed description
Data pending
- Conditions
- Vocal Cord Paralysis
- Being tested
- pacemaker
- Keywords
- Bilateral vocal cord paralyses, Implanted laryngeal stimulator, vocal cord opening, pulmonary function tests
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pacemakerDevice
Placement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study start1 Jan 2006
- Primary completion1 Jan 2009
- Study completion1 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Broniatowski, MD, Principal investigator, University Hospitals Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845442
- Sponsor's protocol ID
- 08-03-16
- Other IDs
- NIH DC-0066854-01, IDE G980179
- Status last verified
- Jul 2022
- First submitted
- 26 Dec 2007
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Vocal Fold Abduction for Bilateral Paralysis
- ClinicalTrials.gov ID
- NCT00845442
- Acronym / sponsor ID
- 08-03-16
- Conditions
- Vocal Cord Paralysis
- Keywords
- Bilateral vocal cord paralyses, Implanted laryngeal stimulator, vocal cord opening, pulmonary function tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Jan 2009 (actual)
- Study completion
- 1 Nov 2010 (actual)
- First posted
- 18 Feb 2009 (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.
People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.
Detailed description
Data pending
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breathing difficulties from vocal cord paralyses
- Tracheostomy tube
- Ability to understand the purpose of the research
- Appropriate hand motor coordination
Key exclusion criteria (4 listed)
- Lack of understanding the research
- Poor hand motor coordination
- Non-acceptance of tracheostomy
- Inability to passively move the paralyzed vocal cords
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pacemakerPlacement of pacemaker over the chest wall to stimulate the larynx in the neck via a tunneled electrode | Device | – |
Primary outcome
Not reported in the source record.
1 secondary outcome
Tolerance of implanted device
Time frame: 3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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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.
Michael Broniatowski, MD principal investigator
University Hospitals Cleveland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pacemaker in people with Vocal Cord Paralysis, run by University Hospitals Cleveland Medical Center at 1 site 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 22 Jul 2022.