CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Tube Delivery System (TDS)device
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/NCT01496287
NCT01496287N/ACompleted
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Tympanostomy Tube Placement in Children in the Office (Inova Study)

Integra LifeSciences Corporation·interventional·Posted Dec 21, 2011·Updated Aug 6, 2024

In Brief

A clinical study evaluating Tube Delivery System (TDS) for Otitis Media. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media
CountriesUnited States
CollaboratorsAcclarent

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2011
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.5 years ago

Interventions

Tube Delivery System (TDS)device

Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting