CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 53 enrolled
Drug / intervention
tympanostomy tubedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01202578
NCT01202578Phase 3Completed
CompareCT.gov

A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media

Integra LifeSciences Corporation·interventional·Posted Sep 16, 2010·Updated Aug 6, 2024

In Brief

A Phase 3 clinical trial evaluating tympanostomy tube for Otitis Media With Effusion and Acute Otitis Media. Completed, enrolled 53 participants across 4 sites.

Detailed Summary

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media With Effusion, Acute Otitis Media
CountriesUnited States
CollaboratorsAcclarent

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2010
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.8 years ago

Interventions

tympanostomy tubedevice

tympanostomy tube delivery system