## Protocol Section
### Identification Module
**NCT ID:** NCT06429709

**Brief Title:** Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

**Official Title:** Utility of Advanced Ultrasound Otoscope In The Diagnosis of Acute Otitis Media

#### Organization Study ID Info
**ID:** H-50018
#### Organization
**Class:** OTHER
**Full Name:** Baylor College of Medicine
### Status Module
#### Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** OtoNexus Medical Technologies, Inc.

#### Lead Sponsor

**Class:** OTHER

**Name:** Baylor College of Medicine

#### Responsible Party

**Investigator Affiliation:** Baylor College of Medicine

**Investigator Full Name:** Yi-Chun Carol Liu

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of this study is to collect ultrasound signal information and visual otoscopic images with an engineering prototype device for children scheduled for tympanostomy tube surgery for the purpose of algorithm development.

**Detailed Description:** The objective of this study is to collect ultrasound signal information and visual otoscopic images with an engineering prototype device for children scheduled for tympanostomy tube surgery for the purpose of algorithm development.

After informed consent from a parent or guardian is obtained, ultrasound and visual data will be collected for each of the child's ears. The images will be taken with the Advanced Ultrasound Otoscope device. The ear laterality will be noted as well as any infection present in the fluid, non-infected fluid, or normal findings in the middle ear as reported by the surgeon. No identifiable data will be recorded. Each study participant will be given a unique study number that will be linked to the images and middle ear findings. No additional information is gathered including age, sex, name or other PHI. The images and corresponding study data will be stored on a password protected smartphone or tablet as well as on a password protected external hard drive. Other characteristics that will be collected include surgical and lab findings regarding effusion, presence or absence (i.e. effusion). The middle ear fluid which is usually suctioned will be collected in a trap chamber- Tympap- and this collected fluid will be sent to the microbiology laboratory for analysis

Investigators will be collecting ultrasound and visual data from the tympanic membrane. The images the investigators are collecting are optical images of the surface of the tympanic membrane. The waveforms do not traverse the body tissue, the tympanic membrane is a strong reflector, and the signal is returned to the ultrasound transducer for processing the waveform from an analog to a digital signal. The power of the ultrasound signal is 1/1000th of the ultrasound power used for fetal imaging which is considered safe.

### Conditions Module

**Conditions:**

- Otitis Media Recurrent

- Middle Ear Infection

- Ear Infection

**Keywords:**

- Otoscope

- Tympanogram

- Effusion

- Ultrasound

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ultrasound and signal information and visual otoscopic images will be collected with an engineering prototype otoscope device for children scheduled for tympanostomy tube surgery. Images of each of the child's ears will be taken by the advanced ultrasound otoscope device. Data collected will include ear laterality, surgical and lab findings of the effusion (present or absent) and characteristics as reported by the surgeon. The middle ear fluid which is usually suctioned will be collected in a trap chamber- Tympap- and this collected fluid will be send for analysis to microbiology. The pathology results will be recorded to correlate ultrasound signals to surgical findings

**Intervention Names:**

- Device: Advanced Ultrasound Otoscope

**Label:** Algorithm Development

#### Arm Group 2

**Description:** The clinical validation phase includes the same procedures as the algorithm development phase only, the clinical validation phase is a double blind study where ultrasound score is compared to surgical findings and lab analysis.

**Intervention Names:**

- Device: Advanced Ultrasound Otoscope

**Label:** Clinical Validation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Algorithm Development

- Clinical Validation

**Description:** The Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type

**Name:** Advanced Ultrasound Otoscope

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Correlation of device measurements to the gold standard of surgeon's findings at myringotomy. Gather ultrasound data for the four disease states of middle ear effusion (normal, viral infection, bacterial infection, and Adhesive Otitis Media) and correlate the ultrasound waveforms with the surgeon's findings and lab analysis obtained at tympanostomy tube insertion. For estimation of fluid character, the middle ear fluid will be correlated with the surgeon's semiquantitative grading of middle ear fluid. For the analysis of microbiota, the middle ear effusion fluid will be sent to microbiology.

**Measure:** Device Performance

**Time Frame:** 2 years and 6 months

#### Secondary Outcomes

**Description:** Evaluate the usability of the Advanced Ultrasound Otoscope device in pediatric patients as measured by the ability of the device to fit in subjects' external auditory canals and obtain a tympanic mobility measurement(s).

**Measure:** Device Usability

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Newborn to 12 years of age
* Receiving first set of pressure equalization (PE) tubes, even if coordinated with other procedures such as adenoidectomy
* Indication for surgery includes recurrent acute otitis media, chronic otitis media with effusion, Eustachian tube dysfunction, and/or hearing loss.

Exclusion Criteria:

* Cholesteatoma, tympanic membrane perforation, myringitis
* History of PE tube placement or PE tubes currently in place.

**Maximum Age:** 12 Years

**Minimum Age:** 0 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** We will be recruiting patients between 0 months and 12 years of age who meet the listed inclusion criteria and do not meet any of the listed exclusion criteria. We are not selecting patients based on race/ethnicity or gender/sex. Parents must be fluent in either English or Spanish.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rearp@texaschildrens.org

**Name:** Rachel Arp

**Phone:** 936-267-7707

**Role:** CONTACT

**Contact 2:**

**Email:** jxkasay@texaschildrens.org

**Name:** Justine Kasay

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** rearp@texaschildrens.org

- **Name:** Rachel Arp

- **Phone:** 936-267-7707

- **Role:** CONTACT

***Contact 2:***

- **Email:** jxkasay@texaschildrens.org

- **Name:** Justine Kasay

- **Role:** CONTACT

***Contact 3:***

- **Name:** Yi-Chun Liu, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Texas Children's Hospital

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** Baylor College of Medicine

**Name:** Tiffany Raynor, MD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Baylor College of Medicine

**Name:** Yi-Chun Liu, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Baylor College of Medicine

**Name:** Shraddha Mukerji, MD

**Role:** STUDY_CHAIR

**Official 4:**

**Affiliation:** Baylor College of Medicine

**Name:** Jennifer Yan, MD

**Role:** STUDY_CHAIR

**Official 5:**

**Affiliation:** Baylor College of Medicine

**Name:** Sonal Saraiya, MD

**Role:** STUDY_CHAIR

**Official 6:**

**Affiliation:** Baylor College of Medicine

**Name:** Mary E Williamson, MD

**Role:** STUDY_CHAIR

**Official 7:**

**Affiliation:** Baylor College of Medicine

**Name:** Henri Traboulsi, MD

**Role:** STUDY_CHAIR

**Official 8:**

**Affiliation:** Baylor College of Medicine

**Name:** Anna Messner, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M12954

- Name: Otitis

- Relevance: HIGH

- As Found: Ear Infection

- ID: M12956

- Name: Otitis Media

- Relevance: HIGH

- As Found: Otitis Media

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000010031

- Term: Otitis

- ID: D000010033

- Term: Otitis Media

### Misc Info Module

- Version Holder: 2024-05-31
