Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01202578 | Evaluation of the Tympanostomy Tube Delivery System | PHASE2 | COMPLETED | 53 | — | — | Sep 1, 2010 | Dec 1, 2010 | Aug 6, 2024 | 4 | United States |
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
| Arm | Type | Description |
|---|---|---|
| tympanostomy tube | EXPERIMENTAL | performance and safety of tympanostomy tube delivery system |
| Name | Type | Description |
|---|---|---|
| tympanostomy tube | DEVICE | tympanostomy tube delivery system |
Inclusion Criteria: * Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion Exclusion Criteria: * Reaction to anesthesia * Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane * Ot...