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Tube Delivery System
Tube placement group for Ear Infection (Inova 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post procedure
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Device Success
Number of Participants With Procedural, Serious, and Device-Related Adverse Events
Secondary outcome measures
Procedure Success
Procedure Tolerability
Tube Retention
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tube placement groupExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tube Delivery System (TDS)
2011
N/A
~70
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Who is running the clinical trial?
Integra LifeSciences CorporationLead Sponsor
107 Previous Clinical Trials
11,372 Total Patients Enrolled
AcclarentIndustry Sponsor
22 Previous Clinical Trials
1,901 Total Patients Enrolled
Jacob W Zeiders, M.D.Principal InvestigatorSouth Coast Ear, Nose & Throat
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