Normal Middle Ears.NCT00794105
Observation of Gas Exchange in the Middle Ear
An observational study of Normal Middle Ears. and Otitis Media Ears., run by Shaare Zedek Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 8 to 80 years
- Conditions the study is for
- Normal Middle Ears., Otitis Media Ears.
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated as a routine treatment in the outpatient or patients admitted for treatment of sudden hearing loss.
Who may be able to join
- Patients having perforated eardrum.
Who cannot join
- Non cooperative patients.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Otolaryngology Dept., Shaare Zedek Medical Center
Jerusalem, 91031
About this study
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.
Read the 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.
- Conditions
- Normal Middle Ears., Otitis Media Ears.
- Keywords
- Gas, Middle ear
- Medical subject headings
- Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal ears | Not described | |
| Otitis media ears. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of air bubbles.
Measured: one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Middle Ears.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794105
- Sponsor's protocol ID
- cohenmed.CTIL
- Status last verified
- Nov 2008
- First submitted
- 18 Nov 2008
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Gas Exchange in the Middle Ear
- ClinicalTrials.gov ID
- NCT00794105
- Acronym / sponsor ID
- cohenmed.CTIL
- Conditions
- Normal Middle Ears., Otitis Media Ears.
- Keywords
- Gas, Middle ear
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Nov 2008
- First posted
- 19 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal ears | – | – |
| Otitis media ears. | – | – |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated as a routine treatment in the outpatient or patients admitted for treatment of sudden hearing loss.
Key inclusion criteria (1 listed)
- Patients having perforated eardrum.
Key exclusion criteria (1 listed)
- Non cooperative patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of air bubbles.
Time frame: one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Middle Ears. and Otitis Media Ears., run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Cohen, MD (+ 972 50 8685888, cohendv@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of air bubbles. (time frame: one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2008.