SWIR Device for Ear Infections

Recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Age under 1, Age 18+, others

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

Trial Summary

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 data supports the effectiveness of the SWIR Otoscopy treatment for ear infections?

Research shows that SWIR Otoscopy can see deeper into the ear than regular methods, helping doctors better identify issues like fluid in the middle ear, which is important for diagnosing ear infections.¹ ² ³ ⁴ ⁵

Is the SWIR Device for Ear Infections safe for humans?

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 safety concerns have been reported in the studies available.¹ ² ⁶ ⁷ ⁸

How does the SWIR device treatment for ear infections differ from other treatments?

The SWIR device for ear infections is unique because it uses shortwave infrared light to see deeper into the ear, allowing doctors to better visualize structures and detect fluid behind the eardrum, which can improve diagnosis and reduce unnecessary antibiotic use.¹ ² ³ ⁹ ¹⁰

What is the purpose of this trial?

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.

Research Team

Tulio Valdez, MD, MSc

Principal Investigator

Stanford University

Eligibility Criteria

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.

See 1 more

Exclusion Criteria

Participants not meeting the inclusion criteria

Timeline

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

Treatment Details

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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: SWIR otoscope + white light otoscopeExperimental Treatment1 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.