Clinical Trial Search

Primary: Procedural Success: — 103; 91 Participants

Primary: Number of Participants With Procedural, Serious, and Device-Related Adverse Events — 0 participants

Primary: Number of Subjects With Post-surgical Otorrhea — 383; 118 Participants

Primary: Safety of Tympanostomy Tube (TT) Delivery System — 0.0 percentage of ears

Primary: Otoscopic Examination: Auricle and Meatus — 1 ears

Primary: The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year — 1.48; 1.56 Occurrences per child-year — p=0.66

Primary: Percentage of Participants Who Were Treatment Failures — 24.6; 44.8 percentage of treatment failures

Primary: Percentage of Participants Who Were Treatment Failures. — 21.3; 45.5 percentage of treatment failures

Primary: Device Success — 21 devices

Primary: Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. — 94.6 percentage of ears

Primary: Percentage of Procedures Converted From Sedation to General Anesthesia — 12.8 percentage of procedures converted

Primary: Proportion of Subjects Who Achieved Anesthesia Effectiveness Per Investigator Assessment — 89.9 percentage of subjects

Primary: Number of Ears With Otorrhea (Drainage From the Middle Ear) — 8 affected ears

Primary: Maximum Postoperative Face, Legs, Activity, Cry and Consolability (FLACC) Pain Score. — 2.9; 2.7; 2.0 units on a scale — p=0.21

Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 76.2; 71.8; 56.8 percentage of participants

Primary: Number of Serious Adverse Events — 0 Serious Adverse Event

Primary: Percentage of Subjects With In-office Tube Placement Procedure Success — 93.2 Percentage of Subjects

Primary: Change in Middle Ear Effusion Over Four Weeks Following an Episode of Acute Otitis Media — 26; 16; 12; 22 Ears — p=0.02

Primary: Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal. — 9.4…

Primary: Percentage of Subjects With Sustained Clinical Cure at Day 8 — 77.1; 75.5; 65.3 percentage of participants

Primary: Number and Type of Contacts With Health Care Providers — 45; 14; 5; 3 Participants

Primary: Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane — 393 Ears

Primary: Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area). — 7; 8 units on a scale

Primary: Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear — 13; 27; 15; 23 participants

Primary: Number of Subjects With Procedural, Serious and Device-related Adverse Events. — 0 subjects

Primary: Ear Outcome Success — 21 ears

Primary: Number of Patients With Tympanic Membrane Closure Following Treatment — 23; 10 Participants

Primary: Resolution of Otitis Media Symptoms — 14.2; 16.5; 7.5; 14.1 units on a scale — p=.002

Primary: Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up — 0.41 percentage of ears

Primary: FLACC Behavioral Pain Assessment Scale Scores — 5; 3; 1; 2 units on a scale