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

NCT01111877 | Terminated

• 1 other identifier: C-09-041
• Study Type: observational
• Target: 1,389
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Otorrhea

Keywords

ear tubes; ear drainage; ear infection; ear drops; tympanostomy tubes; Pediatric patients

Outcome Measures

Primary Outcomes (1)

• Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.

  Up to 1 year

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients between the ages of 6 months and 12 years who are undergoing unilateral or bilateral myringotomy with placement of tympanostomy tube.

You may qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: April 28, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 2, 2012

Record last verified: 2012-01

Locations

US (1)