MedTrace Logo

Tympanostomy Tube Placement in Children in the Office (Inova Study)

NCT01496287 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Otitis Media

Interventions

DEVICE

Tube Delivery System (TDS)

Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting

Sponsors & Collaborators

  • Acclarent

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Jacob W Zeiders, M.D. · South Coast Ear, Nose & Throat

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

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 NCT01496287 on ClinicalTrials.gov