Clinical Research Directory

CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes

This study looks at the safety and performance of the CLiKX device. The device is used to place ear tubes (also called ventilation tubes) in children and adults. These tubes help treat chronic ear fluid (otitis media with effusion) and other conditions where a doctor decides an ear tube is needed. In this study, surgeons will use the CLiKX device to place an ear tube in the patient's ear. The study will check if the surgeon can place the tube correctly in the right position. The procedure will first be attempted with no anesthesia or with local anesthesia. If needed, the surgeon may then use mild sedation or general anesthesia. The study will also look at how well patients tolerate the procedure by checking for side affects during the procedure. Finally, the study will look at how the device affects the procedure and patient safety. Researchers will review how the procedure is performed and will follow patients for up to 30 days after the procedure to continue to check for any side effects..

Parent-led Assessment and Recognition of AOM Using Digital Ear Imaging

Acute otitis media (AOM) is the most common bacterial infection in young children and a major contributor to healthcare utilization and costs. Diagnosis relies on otoscopy and identification of tympanic membrane (TM) bulging, yet physician-performed otoscopy has variable diagnostic accuracy and depends heavily on clinical expertise. Digital otoscopy combined with artificial intelligence (AI)-based image analysis has demonstrated high diagnostic accuracy in previous studies. In a recent study by our group, digital otoscopy with an automated neural network classifier reliably ruled out otitis media in children. The PARENT-EAR randomized controlled pilot trial aims to evaluate whether parent-performed digital otoscopy at home, combined with retrospective AI analysis of captured TM images, can reduce physician visits due to suspicion of AOM. The study also assesses feasibility, diagnostic accuracy of parents after training, and potential effects on antibiotic use and healthcare utilization. Methods and outcomes The PARENT-EAR trial is a randomized controlled pilot trial conducted at Vaasa Central Hospital and Turku University Hospital. Recruitment will occur between September and December 2026 (extended if necessary), with follow-up ending May 31, 2027 (5-9 months per participant). Children aged 12 to 47 months with at least one AOM episode in the past 12 months will be randomized 1:1 using permuted block randomization. Exclusion criteria include tympanostomy tubes, tympanic membrane perforation, middle ear effusion at recruitment, immunosuppression, previously diagnosed hearing loss or anatomical abnormalities predisposing to AOM, and otoscopy experience of the parent. Intervention group: Parents receive a digital otoscope (The Ear Puffin by Sibbo Medical Devices, MDR EU Class I device) and training on TM image interpretation. They complete a TM image classification quiz before and after the training. During follow-up, parents perform home otoscopy when suspecting AOM, capture TM images/videos, interpret findings, and record symptoms in a diary. If AOM is suspected or the child appears ill, medical evaluation is instructed. Control group: Standard care without home otoscopy. Parents complete the same symptom diary and seek care according to usual practice. Statistical analyses will compare outcomes between groups. AI-based TM classification will be compared against expert panel evaluation. This is a pilot study with a target sample size of 20 children per arm, limited by device availability. Ethical aspects, data collection and handling The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all parents after provision of oral and written information. Participation is voluntary, and families may withdraw at any time. Investigators may discontinue participation if deemed in the child's best interest. The digital otoscope is a CE-marked Class I medical device used solely for visual inspection of the tympanic membrane. Pneumatic pumps are not provided. Potential risks include minor ear canal abrasions or discomfort; serious adverse events are considered rare. Any adverse events will be managed according to standard clinical practice and reported to relevant authorities when required. The study is investigator-initiated. The device manufacturer provides the otoscopes but has no role in study design, data access, or analysis. Data will be collected via paper symptom diaries, monthly REDCap questionnaires (University of Turku), and national electronic health records (Kanta). TM images and videos will be securely stored and imported into a research database with relevant metadata. All data will be handled in accordance with the EU General Data Protection Regulation (GDPR 2016/679). Study data will be pseudonymized and identified only by study ID numbers. The key linking personal identifiers to study IDs will be stored separately and securely. Paper diaries will be destroyed after digitalization. Consent includes permission to access health records and to use collected images and data for scientific purposes. Results will be published in peer-reviewed journals and as part of a doctoral thesis.

Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present

To determine whether the use of topical otic drops intra-operative and post-operative during tympanostomy tube placement reduces the rate of tympanostomy tube occlusion and post-operative otorrhea (ear drainage) during the initial 4-week post-operative period in subjects with no middle ear effusion (fluid behind the ear drum) present at the time of surgery. A within subject controlled study design will be utilized to study this effect. Subjects with absent middle ear effusion who are receiving tympanostomy tube placement will receive a standard protocol of Floxin topical drops during surgery and after surgery in one ear. Selection of ear (right ear or left ear) will be randomized. The primary measured outcome will be the rate of tympanostomy tube occlusion within first 4 weeks postoperatively. The secondary measured outcome is the rate of tympanostomy tube otorrhea (drainage) within first 4 weeks postoperatively.

Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device

The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.

Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium

The investigators will conduct a prospective observational study of non-invasive S. pneumoniae infections in Belgium and characterize serotype distributions to evaluate national vaccination programs.

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 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.

Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the new drug for any problems related to the medication. Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes. This problem occasionally is improved with ear drops like Floxin®. However, it is frequently not improved even after this standard ear drop treatment.

Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children

Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm. For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology. Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness. Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy. To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to use for six months at the conclusion of the clinical trial.

Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children

Randomized controlled trial involving 40 pediatric primary care clinicians with high rates of diagnosing and treating middle ear infections. Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month trial: 1) personalized education and feedback about proper ear infection diagnosis; 2) use of a digital otoscope; 3) both education and feedback plus use of a digital otoscope; 4) control (no intervention).

In-Office Clinical Study of the Solo+ TTD

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

Evaluating Laser Otoscope for Middle Ear Effusion Detection

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.

Coherent Optical Detection of Middle Ear Disease

The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely otoscopy will be compared to those made with the addition of OCT.

Validating and AI Software for Assessment of Children With Ear Concerns

The goal of this observational study is to determine if the Glimpse machine learning algorithm can accurately assess ear diseases in children. Participants will: * Have a video of their ear taken by their parent or their guardian * Have a video of their ear taken by a Primary Care Physician (PCP) * Have an assessment of their eardrums and a video of their ears taken by an Ear, Nose, and Throat specialist (ENT). The videos will be used to determine if the Glimpse algorithm matches the diagnosis of the physicians.

Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma

This study focuses on a common side effect experienced by many patients after radiation therapy for nasopharyngeal cancer, which is a type of head and neck cancer. This side effect is called secretory otitis media (fluid buildup in the middle ear). It can cause a feeling of fullness in the ear and hearing loss. While procedures like ear tube placement can help, they can also lead to other problems like ear infections and drainage. Radiation treatment is thought to cause inflammation that disrupts the normal function of the tube connecting the ear to the throat (Eustachian tube), leading to this fluid buildup. A nasal spray containing a steroid medicine (triamcinolone acetonide) is already known to be safe and effective at reducing inflammation in the ear fluid of both children and adults. We believe that using this spray may also help prevent and improve this condition in nasopharyngeal cancer patients after radiation therapy. The main goal of this study is to explore whether this nasal spray can effectively prevent or reduce fluid buildup in the ear following radiation therapy. We hope this non-invasive treatment will provide a new option to improve the quality of life for these patients.

Perspectives on Antibiotics and Tracking Symptoms in Children

The study will assess families' perspectives and decision-making regarding the duration of oral antibiotic courses prescribed to children (4-17 years) who present with uncomplicated bacterial infections at the Royal Children's Hospital (RCH) Emergency Department (ED). The study will involve (i) children discharged from ED on oral antibiotics and (ii) children transferred to Hospital-in-the-Home (HITH) on IV antibiotics who then switch to oral antibiotics. In addition, the study will assess how feasible and acceptable it is to track children's symptoms via the Garmin Smartwatch and the WeGuide platform (WeGuide is a patient engagement software platform that allows for enrolment, consent, and data collection \[via questionnaires/surveys and from the Garmin Smartwatches\] through a singular platform).

Effect of Chitodex Gel in Tympanoplasty Surgery

The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty, ossiculoplasty and mastoidectomy procedures.

Diagnostic Utility of Otosight Middle Ear Scope

Evaluate clinic workflow impact of OtoSight use for patients seen in the pediatric otolaryngology clinic.

Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula® System. The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation. The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION™ otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement. Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 6 months following extrusion or removal of their tube(s).