Chronic Otitis MediaNCT00270660
A Study of the Clinicopathologic Behaviour of the Different Types of Unsafe Chronic Otitis Media
An observational study of Chronic Otitis Media and Cholesteatoma, run by Karnataka Institute of Medical Sciences at 1 site in India.
Trial summary
The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Chronic Otitis Media, Cholesteatoma
- What is being tested?
- biopsy, audiometry, ET function test, ear swab culture, DNE
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 192 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2003to Dec 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- tubotympanic otitis media alone
- otitis media with effusion
- Acute otitis media -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media
The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of otitis media be managed differently?
Read the detailed description
Design: prospective cross sectional study setting: tertiary referral medical college hospital No of groups: 3 group 1: primary acquired atticoantral disease group 2: secondary acquired atticoantral disease group 3: mixed atticoantral disease
Interventions:
- Diagnostic nasal endoscopy
- Eustachian tube function tests
- Pure tone audiometry
- biopsy of middle ear mucosa
- culture and sensitivity of ear discharge
- Conditions
- Chronic Otitis Media, Cholesteatoma
- Being tested
- biopsy, audiometry, ET function test, ear swab culture, DNE
- Keywords
- retraction pockets ear, unsafe otitis media, otitis media complications
- Medical subject headings
- Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy, audiometry, ET function test, ear swab culture, DNEBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startJul 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis MediaStudies 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
- Time perspective
- Other
- Enrolment
- 192 participants
Sponsor and investigators
- Lead sponsor
- Karnataka Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Vikram K Bhat, MS, DNB., Principal investigator, Karnataka Institute of Medical Sciences, Hubli, IndiaKhaja Naseeruddin, MS, DLO., Study director, Vijayanagar Institute of Medical Sciences, Bellary, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270660
- Sponsor's protocol ID
- M06a/2003-04
- Status last verified
- Dec 2005
- First submitted
- 23 Dec 2005
- Last updated
- 30 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study of Clinicopathologic Behaviour of Primary, Secondary and Mixed Types of Atticoantral Chronic Otitis Media
- ClinicalTrials.gov ID
- NCT00270660
- Acronym / sponsor ID
- M06a/2003-04
- Conditions
- Chronic Otitis Media, Cholesteatoma
- Keywords
- retraction pockets ear, unsafe otitis media, otitis media complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 192 participants
- Lead sponsor
- Karnataka Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2003
- Study completion
- Dec 2005
- First posted
- 28 Dec 2005 (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.
The purpose of the study is to study the clinicopathologic behaviour of the 3 dangerous types of chronic otitis media that are prone for complications. In which type are the complications more common? Which type gives rise to more hearing loss? How does the disease process in the 3 types evolve? should the 3 types of otitis media be managed differently?
Detailed description
Design: prospective cross sectional study setting: tertiary referral medical college hospital No of groups: 3 group 1: primary acquired atticoantral disease group 2: secondary acquired atticoantral disease group 3: mixed atticoantral disease
Interventions:
- Diagnostic nasal endoscopy
- Eustachian tube function tests
- Pure tone audiometry
- biopsy of middle ear mucosa
- culture and sensitivity of ear discharge
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- tubotympanic otitis media alone
- otitis media with effusion
- Acute otitis media -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy, audiometry, ET function test, ear swab culture, DNE | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2006.
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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.
Vikram K Bhat, MS, DNB. principal investigator
Karnataka Institute of Medical Sciences, Hubli, India
Khaja Naseeruddin, MS, DLO. study director
Vijayanagar Institute of Medical Sciences, Bellary, India
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 Chronic Otitis Media and Cholesteatoma, run by Karnataka Institute of Medical Sciences at 1 site in India.
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 0 inclusion and 3 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 30 Nov 2006. 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 India. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 30 Nov 2006.