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Clinical Study of the Tympanostomy Tube Delivery System

NCT00939796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-06

Study results available
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Summary

The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Conditions

  • Otitis Media With Effusion

Interventions

DEVICE

Acclarent Tympanostomy Tube Delivery System

A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Charles Syms, III, MD · Ear Medical Group

  • Charles Wilson, MD · Bay Area ENT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939796 on ClinicalTrials.gov