NCT00270660

Brief 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 otitis media be managed differently?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
Last Updated

November 30, 2006

Status Verified

December 1, 2005

First QC Date

December 23, 2005

Last Update Submit

November 29, 2006

Conditions

Chronic Otitis MediaCholesteatoma

Keywords

retraction pockets earunsafe otitis mediaotitis media complications

Interventions

biopsy, audiometry, ET function test, ear swab culture, DNEBEHAVIORAL

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • tubotympanic otitis media alone
  • otitis media with effusion
  • Acute otitis media -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ENT, KIMS

Hubli, Karnataka, 580021, India

Location

MeSH Terms

Conditions

Cholesteatoma

Interventions

BiopsyHearing

Condition Hierarchy (Ancestors)

KeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesVestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Vikram K Bhat, MS, DNB.

    Karnataka Institute of Medical Sciences, Hubli, India

    PRINCIPAL INVESTIGATOR

  • Khaja Naseeruddin, MS, DLO.

    Vijayanagar Institute of Medical Sciences, Bellary, India

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2005

First Posted

December 28, 2005

Study Start

July 1, 2003

Study Completion

December 1, 2005

Last Updated

November 30, 2006

Record last verified: 2005-12

Locations

IN(1)