- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794105
Observation of Gas Exchange in the Middle Ear
Observation of fluid behavior over a perforated eardrum.
A comparison of the behavior of the gas in normal vs. different kinds of otitis media ears.
Study Overview
Status
Conditions
Detailed Description
Fluid present in middle ears is observed during the regular treatment of patients.
The observation in made during the treatment and not as an additional activity. The fluid is either a steroids solution or sterile normal saline or ear's mucus discharge, all in perforated eardrums, either as a part of their intra-tympanic treatment for sudden hearing loss, or traumatic perforation [considered as the normal ears] compared to otitis media ears.
The observation is made on bubble formation over the perforation. The time length of the inspection is about 1 minute, under the microscope, during the treatment.
Study Type
Contacts and Locations
Study Locations
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Jerusalem, Israel, 91031
- Otolaryngology Dept., Shaare Zedek Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients having perforated eardrum.
Exclusion Criteria:
- Non cooperative patients.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Normal ears
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Otitis media ears.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Creation of air bubbles.
Time Frame: one year.
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one year.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- cohenmed.CTIL
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