SWIR Device for Ear Infections

Not yet recruiting at 2 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Age under 1, Age 18+, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool, the SWIR otoscope, to determine if it diagnoses middle ear infections more accurately than the regular white light otoscope. The study involves children already scheduled for a procedure to place tubes in their ears, a common treatment for repeated ear infections. Researchers will examine participants' ears with both the regular and SWIR otoscopes to check for fluid, and the procedure will confirm the findings. Children undergoing this procedure at Lucile Packard Children's Hospital are ideal candidates for this trial. As an unphased study, this trial provides a unique opportunity to advance diagnostic tools for ear infections in children.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this SWIR device is safe for diagnosing ear infections?

Research has shown that the SWIR otoscope is safe for humans. It functions like regular otoscopes, which doctors use to examine the inside of the ear. Studies have not identified any negative effects specific to the SWIR otoscope, indicating it is well-tolerated by patients. This device enhances the view of the middle ear, potentially improving the diagnosis of ear infections. Overall, the SWIR otoscope appears to be a safe choice for ear exams. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SWIR otoscope is unique because it uses short-wave infrared (SWIR) technology to capture images of the middle ear. Unlike the standard white light otoscopes, which can sometimes struggle to provide clear images due to lighting or visibility issues, the SWIR otoscope offers enhanced imaging capabilities that may allow for better visualization of ear structures. Researchers are excited about this technology because it could lead to more accurate diagnoses of ear infections and potentially improve outcomes for patients undergoing tympanostomy tube placements.

What evidence suggests that the SWIR otoscope is effective for diagnosing ear infections?

Research has shown that the short wave infrared (SWIR) otoscope might outperform traditional white light otoscopes in diagnosing middle ear infections, such as otitis media. In this trial, participants will have their middle ears imaged with both the SWIR otoscope and the white light otoscope. Studies have found that SWIR otoscopy provides a clearer view of the structures and fluid in the middle ear by detecting how the fluid absorbs light. This clarity could help doctors identify infections more accurately. Early results suggest it is a promising tool for spotting fluid build-up in the ear, which is common in ear infections. The SWIR otoscope's ability to detect the presence and type of fluid could make it a powerful diagnostic tool. ^{1 5 6 7 8}

Who Is on the Research Team?

Tulio Valdez, MD, MSc

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children aged 1-17 who are patients at the Ear, Nose, and Throat Clinic at Lucile Packard Children's Hospital. They must be undergoing a tympanostomy tube placement procedure as part of their standard care. Participants or their parents must understand and be willing to sign consent forms.

Inclusion Criteria

Being seen in the Ear, Nose, and Throat Clinic at Lucile Packard Childrens Hospital

I am getting ear tubes placed as part of my routine care.

I am between 1 and 17 years old.

Exclusion Criteria

Participants not meeting the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Patients undergo tympanostomy tube placement and imaging with SWIR and white light otoscopes

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SWIR Otoscopy

Trial Overview The study tests if a SWIR otoscope can better diagnose middle ear infections compared to a traditional white light otoscope. During the standard tympanostomy tube placement, imaging with both devices will assess the presence of fluid in the ear.

How Is the Trial Designed?

Group I: SWIR otoscope + white light otoscope Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8206083/

Shortwave infrared otoscopy for diagnosis of middle ear ... We developed an otoscope that visualizes middle ear structures and fluid in the shortwave infrared region, holding several advantages over traditional ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06944795

Study Details | NCT06944795 | SWIR Otoscopy Study 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 ...

3. pnas.org pnas.org/doi/10.1073/pnas.1610529113

Using the shortwave infrared to image middle ear ... As otitis media is the most common pathology observed with an otoscope, we investigated the potential of SWIR light to improve the accuracy of this diagnosis.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587618304221

Initial findings of shortwave infrared otoscopy in a pediatric ... First, a SWIR otoscope could help identify middle ear effusions based on the strong light absorption by middle ear fluid in the SWIR spectral region. Second ...

5. med.stanford.edu med.stanford.edu/content/dam/sm/bogyolab/documents/YimACSSensors.pdf

Short-Wave Infrared Fluorescence Chemical Sensor for ... The ability to simultaneously determine fluid presence and composition using the SWIR otoscope and 6QC-ICG can serve as a powerful tool that ...

6. nature.com nature.com/articles/s41598-021-91736-9

Shortwave infrared otoscopy for diagnosis of middle ear ... All 55 ears were recorded using the SWIR otoscope. Of these, 19 ears (35%) were found to have a middle ear effusion; 36 (65%) did not. Each 55 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7077808/

Initial findings of Shortwave Infrared Otoscopy in a ... First, a SWIR otoscope could help identify middle ear effusions based on the strong light absorption by middle ear fluid in the SWIR spectral region. Second ...

8. withpower.com withpower.com/trial/phase-otitis-media-4-2025-91096

SWIR Device for Ear Infections · Info for Participants The research on SWIR otoscopy suggests it is safe for use in humans, as it is similar to conventional otoscopes in terms of operation and ergonomics, and no ...