SWIR Otoscopy Study

NCT06944795 | Not Yet Recruiting FDA Device

• 2 other identifiers: IRB 44549R01DC021326
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.

Conditions

Otitis Media; Otitis Media Chronic; Otitis Media Effusion

Keywords

middle ear infections; ear infections; pediatric ear infections; otitis media; chronic otitis media; chronic otitis media with effusion

Outcome Measures

Primary Outcomes (1)

• Number of accurate diagnoses made by SWIR otoscope as confirmed by presence/absence of fluid during tympanostomy tube placement

  Patients who are having a tympanostomy tube placement procedure at the LPCH will undergo removal of middle ear fluid as part of their standard of care. During the procedure, the physician will use the SWIR otoscope to take images using the SWIR and the white light otoscope. The physician conducting the procedure will take note of whether there was a presence of absence of middle ear fluid. A different physician and a computer program. The accuracy of the otscopes will be determined by comparing the physician and program's diagnoses to physical presence of fluid when the ear is drained during the tympanostomy tube placement.

  30 minutes

Study Arms (1)

SWIR otoscope + white light otoscope

EXPERIMENTAL

Patients who are undergoing a tympanostomy tube placement as part of standard of care will have their middle ears imaged with the SWIR otoscope. The SWIR otoscope will record images/recordings of the SWIR otoscope and the white light otoscope, therefore, there will only be one arm of the study because all patients will be imaged with the white light and the SWIR.

Device: SWIR device

Interventions

SWIR device DEVICE

A Short Wave Infrared (SWIR) Otoscope will record images for both the SWIR and white light video otoscopes. These images of the middle ear will be recorded in AVI format.

SWIR otoscope + white light otoscope

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 1-17
• Being seen in the Ear, Nose, and Throat Clinic at Lucile Packard Childrens Hospital
• Undergoing tympanostomy tube placement as part of standard of care
• Parents and/or patient has the ability to understand and the willingness to sign a written informed consent form or assent form.

You may not qualify if:

• Patients under 1 year of age or 18 and older

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94304, United States

Location

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (6)

• Martynkina LP, Vengerov IuIu, Bespalova IA, Sergeeva GI, Tikhonenko AS. [Structure of the interphase chromatin in the ciliata Bursaria truncatella macronucleus. II. Loop organization of inactive chromatin clumps]. Mol Biol (Mosk). 1984 Jan-Feb;18(1):272-6. Russian.

  PMID: 6423968 BACKGROUND

• Kashani RG, Mlynczak MC, Zarabanda D, Solis-Pazmino P, Huland DM, Ahmad IN, Singh SP, Valdez TA. Shortwave infrared otoscopy for diagnosis of middle ear effusions: a machine-learning-based approach. Sci Rep. 2021 Jun 15;11(1):12509. doi: 10.1038/s41598-021-91736-9.

  PMID: 34131163 BACKGROUND

• Pichichero ME. Diagnostic accuracy, tympanocentesis training performance, and antibiotic selection by pediatric residents in management of otitis media. Pediatrics. 2002 Dec;110(6):1064-70. doi: 10.1542/peds.110.6.1064.

  PMID: 12456901 BACKGROUND

• Pichichero ME, Poole MD. Assessing diagnostic accuracy and tympanocentesis skills in the management of otitis media. Arch Pediatr Adolesc Med. 2001 Oct;155(10):1137-42. doi: 10.1001/archpedi.155.10.1137.

  PMID: 11576009 BACKGROUND

• Coker TR, Chan LS, Newberry SJ, Limbos MA, Suttorp MJ, Shekelle PG, Takata GS. Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children: a systematic review. JAMA. 2010 Nov 17;304(19):2161-9. doi: 10.1001/jama.2010.1651.

  PMID: 21081729 BACKGROUND

• Grubb MS, Spaugh DC. Treatment failure, recurrence, and antibiotic prescription rates for different acute otitis media treatment methods. Clin Pediatr (Phila). 2010 Oct;49(10):970-5. doi: 10.1177/0009922810370363. Epub 2010 Jun 3.

  PMID: 20522607 BACKGROUND

MeSH Terms

Conditions

Otitis Media; Otitis Media with Effusion; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Tulio Valdez, MD, MSc

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The physician who performs the tympanostomy tube placement procedure will not be analyzing the SWIR otoscope images. A different physician and a computer program will analyze the images for presence or absence of fluid.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology - Head & Neck Surgery

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)