Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years

Terminated

• Conditions: Otorrhea

• Registration Number: NCT01111877
• Lead Sponsor: Alcon Research

Brief Summary

This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-26
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2010-05
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1389

Inclusion Criteria

• Participants must be at least 6 months old and no more than 13 years of age at the time of enrollment scheduled for unilateral or bilateral myringotomy and tympanostomy tube insertion. Patients and/or child must read/sign informed consent and comply with requirement of the study.

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Exclusion Criteria

• There are no exclusion criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.	Up to 1 year

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States