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Observation of Gas Exchange in the Middle Ear

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00794105
First Posted: November 19, 2008
Last Update Posted: November 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shaare Zedek Medical Center
  Purpose

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.


Condition
Normal Middle Ears. Otitis Media Ears.

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Creation of air bubbles. [ Time Frame: one year. ]

Study Start Date: November 2008
Groups/Cohorts
Normal ears
Otitis media ears.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated as a routine treatment in the outpatient or patients admitted for treatment of sudden hearing loss.
Criteria

Inclusion Criteria:

  • Patients having perforated eardrum.

Exclusion Criteria:

  • Non cooperative patients.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794105


Contacts
Contact: David Cohen, MD + 972 50 8685888 cohendv@netvision.net.il

Locations
Israel
Otolaryngology Dept., Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
  More Information

Responsible Party: David Cohen, MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00794105     History of Changes
Other Study ID Numbers: cohenmed.CTIL
First Submitted: November 18, 2008
First Posted: November 19, 2008
Last Update Posted: November 19, 2008
Last Verified: November 2008

Keywords provided by Shaare Zedek Medical Center:
Gas
Middle ear

Additional relevant MeSH terms:
Otitis Media
Otitis
Ear Diseases
Otorhinolaryngologic Diseases