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Device

Tympanostomy Tube Placement for Acute Otitis Media (inVENT-visIOn Trial)

N/A
Waitlist Available
Led By Jacob W. Zeiders, M.D.
Research Sponsored by Integra LifeSciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-procedure
Awards & highlights
No Placebo-Only Group

Summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.

Eligible Conditions
  • Acute Otitis Media
  • Ear Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks post-procedure 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
Number of Subjects With Procedural, Serious and Device-related Adverse Events.
Secondary study objectives
Procedure Success
Procedure Tolerability
Tube Retention

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 Tube PlacementExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tympanostomy tube placement (Acclarent iontophoresis device)
2011
N/A
~50

Find a Location

Who is running the clinical trial?

Integra LifeSciences CorporationLead Sponsor
108 Previous Clinical Trials
11,252 Total Patients Enrolled
AcclarentIndustry Sponsor
22 Previous Clinical Trials
1,929 Total Patients Enrolled
Jacob W. Zeiders, M.D.Principal InvestigatorSouth Coast Ear, Nose & Throat
~3 spots leftby Nov 2025
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