Aspiration PneumoniaNCT00580346
Dynamic Laryngotracheal Separation for Aspiration
A study testing Placement of laryngeal implant in people with Aspiration Pneumonia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aspiration Pneumonia
- What is being tested?
- Placement of laryngeal implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Jul 2009
- 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
- Aspiration pneumonia after neurological insults (e.g. stroke)
- Ability to understand the purpose of the research
- Appropriate hand motor control
- Inability to improve under standard treatments (speech-language pathologists)
- Acceptance of a tracheostomy
Who cannot join
- Lack of understanding the research
- Poor hand motor coordination
- Uncontrolled seizures
- Pregnancy
- Refusal to accept a tracheostomy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Health System
Cleveland, Ohio, 44106
About this study
Official title: Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.
Read the detailed description
Data pending
- Conditions
- Aspiration Pneumonia
- Being tested
- Placement of laryngeal implant
- Keywords
- Aspiration pneumonia, Implanted laryngeal stimulator, Vocal cord closure, Modified barium swallow
- Medical subject headings
- Pneumonia, Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of laryngeal implantDevice
Also called Modified Finetech Vocare Bladder stimulator, Huntington perineural electrodes
Placement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Not described Receives: Device: Placement of laryngeal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Videotaping vocal cords and modified barium swallows
Measured: several months
Secondary outcomes (2)
Tolerance of implanted device
Measured: immediate to several years
comfort in swallowing
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startAug 2004
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aspiration PneumoniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 0 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 Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580346
- Sponsor's protocol ID
- 01-01-02
- Other IDs
- NIH DC-006703-01, IDE G980179
- Status last verified
- Jul 2022
- First submitted
- 21 Dec 2007
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Broniatowski M, Grundfest-Broniatowski S, Tyler DJ, Scolieri P, Abbass F, Tucker HM, Brodsky S. Dynamic laryngotracheal closure for aspiration: a preliminary report. Laryngoscope. 2001 Nov;111(11 Pt 1):2032-40. doi: 10.1097/00005537-200111000-00031.
PubMed 11801992
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
- ClinicalTrials.gov ID
- NCT00580346
- Acronym / sponsor ID
- 01-01-02
- Conditions
- Aspiration Pneumonia
- Keywords
- Aspiration pneumonia, Implanted laryngeal stimulator, Vocal cord closure, Modified barium swallow
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 24 Dec 2007 (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 aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.
Detailed description
Data pending
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Device: Placement of laryngeal implant |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aspiration pneumonia after neurological insults (e.g. stroke)
- Ability to understand the purpose of the research
- Appropriate hand motor control
- Inability to improve under standard treatments (speech-language pathologists)
- Acceptance of a tracheostomy
Key exclusion criteria (5 listed)
- Lack of understanding the research
- Poor hand motor coordination
- Uncontrolled seizures
- Pregnancy
- Refusal to accept a tracheostomy
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 |
|---|---|---|
| Placement of laryngeal implantAlso: Modified Finetech Vocare Bladder stimulator, Huntington perineural electrodesPlacement of stimulator over anterior chest wall, and electrodes around recurrent laryngeal nerve, and tunneling leads between both | Device | 2 |
Primary outcome
Videotaping vocal cords and modified barium swallows
Time frame: several months
2 secondary outcomes
Tolerance of implanted device
Time frame: immediate to several years
comfort in swallowing
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 11801992Broniatowski M, Grundfest-Broniatowski S, Tyler DJ, Scolieri P, Abbass F, Tucker HM, Brodsky S. Dynamic laryngotracheal closure for aspiration: a preliminary report. Laryngoscope. 2001 Nov;111(11 Pt 1):2032-40. doi: 10.1097/00005537-200111000-00031.
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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 Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of laryngeal implant in people with Aspiration Pneumonia, 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 21 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 was withdrawn before enrolling participants, so there are no results.
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?
Videotaping vocal cords and modified barium swallows (time frame: several months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00580346, which also lists 1 linked publication.
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 21 Jul 2022.