In-Office Tympanostomy Tube Placement in Children (OTTER)
Public ClinicalTrials.gov record NCT03323736. 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
A Prospective, Single-arm, Multicenter Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Children in an Office Setting.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
Study identification
- NCT ID
- NCT03323736
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 370 participants
Conditions and interventions
Interventions
- Iontophoresis & tube placement Combination Product
- Tube placement Device
Combination Product · Device
Eligibility (public fields only)
- Age range
- 6 Months to 12 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
- Oct 31, 2017 (Actual)
- Primary completion
- Feb 28, 2019 (Actual)
- Completion
- Mar 25, 2021 (Actual)
- Last update posted
- May 26, 2022
2017 – 2021
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| California Head and Neck Specialists | Carlsbad | California | 92008 | — |
| Sacramento ENT | Roseville | California | 95661 | — |
| Camino Ear Nose & Throat Clinic | San Jose | California | 95138 | — |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | — |
| Yale School of Medicine, Section of Otolaryngology | New Haven | Connecticut | 06510 | — |
| South Florida Pediatric Otolaryngology | Fort Lauderdale | Florida | 33316 | — |
| Nemour's Children's Specialty Care | Jacksonville | Florida | 32207 | — |
| Advanced ENT & Allergy | Louisville | Kentucky | 40207 | — |
| Albany ENT & Allergy Services | Albany | New York | 12206 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Charlotte Ear Eye Nose & Throat Associates, PA | Charlotte | North Carolina | 28105 | — |
| Specialty Physician Associates | Bethlehem | Pennsylvania | 18017 | — |
| South Carolina Ear Nose and Throat | Lugoff | South Carolina | 29078 | — |
| Carolina Ear Nose and Throat Clinic | Orangeburg | South Carolina | 29118 | — |
| Ear Nose and Throat Specialists of Abilene | Abilene | Texas | 79601 | — |
| Frisco ENT for Children | Frisco | Texas | 75033 | — |
| Collin County ENT | Frisco | Texas | 75034 | — |
| Ear Medical Group | San Antonio | Texas | 78240 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03323736, 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 May 26, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03323736 live on ClinicalTrials.gov.