MedTrace Logo

Evaluation of the Tympanostomy Tube Delivery System

NCT01202578 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2024-08-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Otitis Media With Effusion
  • Acute Otitis Media

Interventions

DEVICE

tympanostomy tube

tympanostomy tube delivery system

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Kenneth Faw, MD · Evergreen Sinus Center

  • Andrew Gould, MD · Advanced ENT and Allergy

  • Charles Syms, MD · Ear Medical Group

  • Jacob Zeiders, MD · South Coast ENT

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01202578 on ClinicalTrials.gov