Completed

Study to Evaluate the Efficacy of Optical Imaging to Evaluate the Anatomy of the Developing Pediatric Vocal Fold

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What is being collected

Procedure Data

+ procedure Data

Collected from today forward - Prospective
Procedure
Who is being recruted

From 1 Months to 99 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2011
See protocol details

Summary

Principal SponsorMassachusetts Eye and Ear Infirmary
Last updated: May 27, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2011

Actual date on which the first participant was enrolled.

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 The optical imaging probe will then be withdrawn from the patient and the original operative procedure will then be performed.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.

Principal SponsorMassachusetts Eye and Ear Infirmary
Last updated: May 27, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

557 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 Months to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Adults who have given and signed an informed consent and HIPAA Authorization

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 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 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

3 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Massachusetts Eye and Ear

Boston, United StatesOpen Massachusetts Eye and Ear in Google Maps
CompletedOne Study Center