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Device

Evaluation of the Tympanostomy Tube Delivery System (inVENT-OR Trial)

Phase 2 & 3
Waitlist Available
Led By Charles Syms, MD
Research Sponsored by Integra LifeSciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Middle Ear Fluid
  • Ear Infection

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device Success
Safety of Tympanostomy Tube (TT) Delivery System
Secondary study objectives
Proportion of Subjects With Procedure Success
Tube Retention

Side effects data

From 2010 Phase 2 & 3 trial • 53 Patients • NCT01202578
8%
Tube Lumen Occlusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: tympanostomy tubeExperimental Treatment1 Intervention
performance and safety of tympanostomy tube delivery system
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tympanostomy tube
2010
Completed Phase 3
~60

Find a Location

Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor
108 Previous Clinical Trials
11,241 Total Patients Enrolled
AcclarentIndustry Sponsor
22 Previous Clinical Trials
1,918 Total Patients Enrolled
Charles Syms, MDPrincipal InvestigatorEar Medical Group
1 Previous Clinical Trials
15 Total Patients Enrolled
Andrew Gould, MDPrincipal InvestigatorAdvanced ENT and Allergy
Jacob Zeiders, MDPrincipal InvestigatorSouth Coast ENT
Kenneth Faw, MDPrincipal InvestigatorEvergreen Sinus Center
~3 spots leftby Dec 2025
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