Vocal Fold DevelopmentNCT01810107
Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold
An observational study of Vocal Fold Development, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The specific aim of this study is to develop a growth and development chart (similar to a height or weight chart for children) that identifies the pattern of development of the pediatric vocal cord lamina propria from a single to a three layer structure. Read more about this study
- Who is it for?
- Ages 1 month to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Vocal Fold Development
- What is being tested?
- Children Examined with the OCT Probe
- Type of treatment
- Surgery or procedure
- How many people
- 557 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 21 Dec 2019
- Phase
- Observational
- 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 1 month to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children ages 1 month to 18 (and adults >18) undergoing laryngoscopy and bronchoscopy for airway evaluation where the patients will be already scheduled for general anesthesia with intravenous catheter placement as part of standard routine.
Who may be able to join
- Children ages 1 month to 18 (and adults >18) undergoing laryngoscopy and bronchoscopy for airway evaluation where the patients will be already scheduled for general anesthesia with intravenous catheter placement as part of standard routine.
- Children (and adults) undergoing any otolaryngology procedure where there is no indication of airway obstruction or risk of abnormal vocal chords. For instance, children undergoing adenoidectomy, sinus surgery or tracheotomy are all good candidates for studying the normal vocal chord development.
- Children whose parents have given and signed an informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization and who have signed an assent form (if they are 7 and older) agreeing to participate in the study. Eligibility will be determined by the Principal Investigator.
- Adults who have given and signed an informed consent and HIPAA Authorization.
Who cannot join
- Children (or adults) with any form of laryngeal anomaly or pathology.
- Children who have previously been intubated.
- Children, adolescents, and adults who smoke. Exclusion will be determined by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear
Boston, Massachusetts, 02115
About this study
The specific aim of this study is to develop a growth and development chart (similar to a height or weight chart for children) that identifies the pattern of development of the pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim is to identify whether this growth chart shows a pattern of linear development or whether there are clear critical periods of development.
Read the detailed description
The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. A Universal Modular Glottiscope will be utilized for adequate laryngeal exposure. An operating microscope will be used for magnification. This setup will allow for the Optical Coherence Tomography (OCT) imaging probe to be introduced using a laryngoscope to provide stability. The optical imaging probe will then be directed, or gently applied towards, the glottal surface, and an image field of 500 microns x 500 microns x 350 microns will be obtained. As the probe is moved along the medial and superior mucosal surfaces of the vocal folds, "real-time" images will be obtained and digitally stored for review. The digitally stored images will be assessed and analyzed for their optical characteristics. The optical imaging probe will then be withdrawn from the patient and the original operative procedure will then be performed. Images can be attained in both "non-contact" mode (where the probe tip remains in the space between each vocal fold) and "contact" mode (where the probe tip is gently placed against the glottal tissue to compress it). The contact mode allows for deeper imaging (much like an ultrasound), which would be useful in situations involving larger (thicker) vocal folds. The study will end when images are acquired from a range of developmental ages to be able to refine the optical characteristics of the optical imaging system.
Adults have also been included in this study for comparison as OCT imaging in adults may confirm the number of vocal fold layers compared to children.
- Conditions
- Vocal Fold Development
- Being tested
- Children Examined with the OCT Probe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children Examined with the OCT ProbeProcedure or surgery
The child undergoing therapy will have the Optical Coherence Tomography (OCT) probe to examine the vocal fold.
| Study group | Role | What they receive |
|---|---|---|
| Children Examined with the OCT Probe | Children undergoing surgery will also have the Optical Coherence Tomography probe. Receives: Procedure: Children Examined with the OCT Probe | |
| Adults | Adults undergoing surgery will also have the Optical Coherence Tomography probe. Receives: Procedure: Children Examined with the OCT Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocal Fold Development
The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. The major analysis will be to validate the age dependent laminar structure using a cohort of 720 subjects between age 0-18 as well as estimate the probability of future events of developing two- or three laminar structure given a subject's age. We will perform one-sided two-sample binomial tests to examine as well as model the patterns of the rates of bi- and tri-laminar structure patterns by using logistic model or discrete or continuous time Cox's proportional hazards model of which the predictor variables are determined based on the discriminant model described above. In addition, as a parallel approach we will analyze the Optical Coherence Tomography (OCT) data of each of the trilaminar system by using linear or curve-linear regression models which will provide a prediction model of the mean OCT at various critical ages.
Measured: 30 seconds to a minute, in the operating room, before the otolaryngology procedure that they are originally there for. This time frame is all that is needed to image their vocal cords.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startJul 2011
- Primary completion26 Sep 2019
- Study completion21 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Fold DevelopmentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hartnick, M.D., Massachusetts Eye and Ear Infirmary
- Investigators
- Christopher Hartnick, MD, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810107
- Sponsor's protocol ID
- 11-006H
- Status last verified
- May 2020
- First submitted
- 19 Oct 2012
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold
- ClinicalTrials.gov ID
- NCT01810107
- Acronym / sponsor ID
- 11-006H
- Conditions
- Vocal Fold Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 13 Mar 2013 (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.
The specific aim of this study is to develop a growth and development chart (similar to a height or weight chart for children) that identifies the pattern of development of the pediatric vocal cord lamina propria from a single to a three layer structure. A secondary aim is to identify whether this growth chart shows a pattern of linear development or whether there are clear critical periods of development.
Detailed description
The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. A Universal Modular Glottiscope will be utilized for adequate laryngeal exposure. An operating microscope will be used for magnification. This setup will allow for the Optical Coherence Tomography (OCT) imaging probe to be introduced using a laryngoscope to provide stability. The optical imaging probe will then be directed, or gently applied towards, the glottal surface, and an image field of 500 microns x 500 microns x 350 microns will be obtained. As the probe is moved along the medial and superior mucosal surfaces of the vocal folds, "real-time" images will be obtained and digitally stored for review. The digitally stored images will be assessed and analyzed for their optical characteristics. The optical imaging probe will then be withdrawn from the patient and the original operative procedure will then be performed. Images can be attained in both "non-contact" mode (where the probe tip remains in the space between each vocal fold) and "contact" mode (where the probe tip is gently placed against the glottal tissue to compress it). The contact mode allows for deeper imaging (much like an ultrasound), which would be useful in situations involving larger (thicker) vocal folds. The study will end when images are acquired from a range of developmental ages to be able to refine the optical characteristics of the optical imaging system.
Adults have also been included in this study for comparison as OCT imaging in adults may confirm the number of vocal fold layers compared to children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children Examined with the OCT Probe | – | Procedure: Children Examined with the OCT ProbeChildren undergoing surgery will also have the Optical Coherence Tomography probe. |
| Adults | – | Procedure: Children Examined with the OCT ProbeAdults undergoing surgery will also have the Optical Coherence Tomography probe. |
Who may qualify
- Ages
- 1 month to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children ages 1 month to 18 (and adults >18) undergoing laryngoscopy and bronchoscopy for airway evaluation where the patients will be already scheduled for general anesthesia with intravenous catheter placement as part of standard routine.
Key inclusion criteria (4 listed)
- Children ages 1 month to 18 (and adults >18) undergoing laryngoscopy and bronchoscopy for airway evaluation where the patients will be already scheduled for general anesthesia with intravenous catheter placement as part of standard routine.
- Children (and adults) undergoing any otolaryngology procedure where there is no indication of airway obstruction or risk of abnormal vocal chords. For instance, children undergoing adenoidectomy, sinus surgery or tracheotomy are all good candidates for studying the normal vocal chord development.
- Children whose parents have given and signed an informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization and who have signed an assent form (if they are 7 and older) agreeing to participate in the study. Eligibility will be determined by the Principal Investigator.
- Adults who have given and signed an informed consent and HIPAA Authorization.
Key exclusion criteria (3 listed)
- Children (or adults) with any form of laryngeal anomaly or pathology.
- Children who have previously been intubated.
- Children, adolescents, and adults who smoke. Exclusion will be determined by the Principal Investigator.
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 |
|---|---|---|
| Children Examined with the OCT ProbeThe child undergoing therapy will have the Optical Coherence Tomography (OCT) probe to examine the vocal fold. | Procedure or surgery | Adults, Children Examined with the OCT Probe |
Primary outcome
Vocal Fold Development
Time frame: 30 seconds to a minute, in the operating room, before the otolaryngology procedure that they are originally there for. This time frame is all that is needed to image their vocal cords.
The goal of this study is to identify critical periods of development when the lamina propria structure of the pediatric vocal fold matures. The major analysis will be to validate the age dependent laminar structure using a cohort of 720 subjects between age 0-18 as well as estimate the probability of future events of developing two- or three laminar structure given a subject's age. We will perform one-sided two-sample binomial tests to examine as well as model the patterns of the rates of bi- and tri-laminar structure patterns by using logistic model or discrete or continuous time Cox's proportional hazards model of which the predictor variables are determined based on the discriminant model described above. In addition, as a parallel approach we will analyze the Optical Coherence Tomography (OCT) data of each of the trilaminar system by using linear or curve-linear regression models which will provide a prediction model of the mean OCT at various critical ages.
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 27 May 2020.
- Individual participant dataSharing planned: No
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.
Christopher Hartnick, MD principal investigator
Massachusetts Eye and Ear Infirmary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Fold Development, run by Massachusetts Eye and Ear Infirmary 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 3 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 27 May 2020. 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.
What does the primary outcome measure?
Vocal Fold Development (time frame: 30 seconds to a minute, in the operating room, before the otolaryngology procedure that they are originally there for. This time frame is all that is needed to image their vocal cords.). It is what the study was designed to measure, not a finding.
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 27 May 2020; AzTrials last refreshed its copy on 2 Nov 2026.