Observation of Gas Exchange in the Middle Ear

Normal Middle Ears. Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00794105
• Other study ID #: cohenmed.CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: November 18, 2008
• Last updated: November 18, 2008
• Start date: November 2008

Study information

• Verified date: November 2008
• Source: Shaare Zedek Medical Center
• Contact: David Cohen, MD
• Phone: + 972 50 8685888
• Email: cohendv[@]netvision.net.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients having perforated eardrum.

Exclusion Criteria:

• Non cooperative patients.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Normal Middle Ears.
• Otitis Media
• Otitis Media Ears.

Locations

Country	Name	City	State
Israel	Otolaryngology Dept., Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creation of air bubbles.		one year.	No