CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Tympanostomy Tube Delivery Systemdevice
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/NCT01046877
NCT01046877N/ACompleted

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 Jan 12, 2010·Updated Aug 6, 2024

In Brief

A clinical study evaluating Tympanostomy Tube Delivery System for Otitis Media. Completed, enrolled 25 participants across 1 site.

Detailed Summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media
CountriesSingapore
CollaboratorsAcclarent

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 12, 2010
Enrollment StartDec 1, 2008
Primary CompletionAug 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 16.5 years ago

Interventions

Tympanostomy Tube Delivery Systemdevice

Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)