Evaluating Laser Otoscope for Middle Ear Effusion Detection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorMSTATT LLC
About this trial
The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are:
-Accuracy and usability of doctors using laser otoscopes
Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement
Between the ages of 6 months to 18 years at the time of consent
Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection
Disqualifiers
History of prior ear tube placement
Anatomical abnormalities of the tympanic membrane or ear canal
Presence of excessive cerumen that cannot be removed pre-exam and may interfere with study procedures
Any of the following deformities of the external ear and tympanic membrane: congenital canal stenosis or atresia, severe canal tortuosity or curvature which prevents visualizing the tympanic membrane fully with an otoscope, canal wall exostoses or osteomas, markedly thickened or opaque tympanic membranes such as caused by chronic myringitis, or scarring or fibrosis of the tympanic membrane, tympanosclerosis or other heavy calcification of the tympanic membrane, tympanic membrane perforations, and grafted tympanic membranes.
Trial population
Pediatric patients ages 6 months to 18 years who are scheduled to undergo unilateral or bilateral myringotomy with ear tube placement (tympanostomy) as part of their standard clinical care. Eligible participants will be identified prior to surgery based on clinical scheduling and medical history.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Laser otoscope examination
DevicePatients will have short videos taken of their tympanic membranes under white light and laser illumination.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Investigational cohort1 intervention
Trial outcomes
Primary outcomes
1
Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence
The primary endpoint is the accuracy, PPV, and NPV of the MEEscope in detecting MEE validated by myringotomy findings. These values will be compared to the standard white-light otoscopy findings in the same patients to demonstrate the relative accuracy of the experimental illumination vs white light illumination in detection of MEE.
Time frame
From enrollment to data collection at tympanostomy typically at 2-3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
MSTATT LLC
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: