Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Public ClinicalTrials.gov record NCT05915078. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05915078
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 200 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 6 Months to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 14, 2023
- Primary completion
- Mar 29, 2025
- Completion
- Jun 29, 2027
- Last update posted
- Jul 22, 2024
2023 – 2027
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced ENT and Allergy | Louisville | Kentucky | 40220 | Recruiting |
| Regional Otolaryngology Head and Neck Associates | Cherry Hill | New Jersey | 08034 | Recruiting |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | Recruiting |
| Columbia University Vagelos College of Physicians and Surgeons | New York | New York | 10032 | Recruiting |
| Ogden Clinic - Professional Center North | Ogden | Utah | 84403 | Recruiting |
| Peak Pediatric Ear, Nose and Throat | Provo | Utah | 84604 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Recently updated Acute Otitis Media trials
Other public records listing Acute Otitis Media. Sorted by last update posted; newest first. Not a recommendation.
- NCT06034080: Interventions to De-implement Unnecessary Antibiotic Prescribing for Children With Ear Infections Recruiting
- NCT05608993: RELAX: Reducing Length of Antibiotics for Children With Ear Infections Active, not recruiting
- NCT04946084: Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens Active, not recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05915078, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2024 · Synced Jul 29, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05915078 live on ClinicalTrials.gov.