Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
Public ClinicalTrials.gov record NCT03197558. 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, Multicenter Study to Evaluate Effectiveness and Safety of Lidocaine Iontophoresis and Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Adults in an Office Setting
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting. This study cohort is called Group B and includes tube placement. Protocol CPR007003 also included a first study group ('A', without tube placement) that was completed and described in a separate registration (NCT03119181).
Study identification
- NCT ID
- NCT03197558
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Interventions
- Tymbion Iontophoresis and Tube Delivery System (TDS) Combination Product
Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 27, 2017 (Actual)
- Primary completion
- Sep 14, 2017 (Actual)
- Completion
- Sep 14, 2017 (Actual)
- Last update posted
- Jan 18, 2020
2017
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sacramento ENT | Roseville | California | 95661 | — |
| Camino ENT | San Jose | California | 95138 | — |
| Advanced ENT and Allergy | Louisville | Kentucky | 40207 | — |
| Charlotte Eye Ear Nose and Throat Associates | Charlotte | North Carolina | 28105 | — |
| Specialty Physician Associates | Bethlehem | Pennsylvania | 18017 | — |
| South Carolina ENT | Lugoff | South Carolina | 29078 | — |
| Carolina Ear, Nose and Throat | Orangeburg | South Carolina | 29118 | — |
| 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.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03197558, 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 Jan 18, 2020 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03197558 live on ClinicalTrials.gov.