CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
Acclarent Tympanostomy Tube Delivery system (TTDS)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/NCT01324271
NCT01324271N/ACompleted
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A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office

Integra LifeSciences Corporation·interventional·Posted Mar 29, 2011·Updated Aug 6, 2024

In Brief

A clinical study evaluating Acclarent Tympanostomy Tube Delivery system (TTDS) for Otitis Media. Completed, enrolled 85 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) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Study Details

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

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2011
Enrollment StartJan 1, 2011
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.3 years ago

Interventions

Acclarent Tympanostomy Tube Delivery system (TTDS)device

placement of tympanostomy tube under local anesthesia