CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Acclarent 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/NCT00939796
NCT00939796N/ACompleted
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A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)

Integra LifeSciences Corporation·interventional·Posted Jul 15, 2009·Updated Aug 6, 2024

In Brief

A clinical study evaluating Acclarent Tympanostomy Tube Delivery System for Otitis Media With Effusion. Completed, enrolled 16 participants across 2 sites.

Detailed Summary

The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] 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 With Effusion
CountriesUnited States
CollaboratorsAcclarent

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.0 years ago

Interventions

Acclarent Tympanostomy Tube Delivery Systemdevice

A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media