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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611842
Other study ID # RECHMPL18_0306
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2018
Est. completion date November 30, 2018

Study information

Verified date July 2018
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy.

The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.


Description:

The investigator will include 35 children under 12 years old with OME and who need tympanostomy or tube placement under general anesthesia. Middle ear effusion will be collected, divided in two and frozen.

The investigator will perform ELISA tests to measure the level of MMP2 MMP9 MMP7 et TIMP2 (inhibitor of MMPs). The investigator want to compare the level of MMPs between healthy eardrum and atrophic membrane.

Clinical data will be collected such as age, gender, chronicity of the OME, quality of the eardrum and middle ear effusion type to see if there is any difference when MMPs level is higher.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date November 30, 2018
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Years
Eligibility Inclusion Criteria:

- every children under 12 yo operated on in Gui de Chauliac Hospital

Exclusion criteria:

- when effusion is not possible to collect (too thick or amount of fluid not enough)

Collection of both MEE on each ear when OME is bilateral. We will perform the tests on only one ear. The other one will be kept in case of technical issue. A random draw will establish which ear will be tested.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
preservation of mucosal otitis media
Suction of the middle ear fluid and conservation of the fluid to be collected instead of thrown away into children Healthy eardrum and Atrophic eardrum

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier INM : institut des neurosciences Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microscopic evaluation of the quality of the eardrum : normal or atrophic Microscopic evaluation of the quality of the eardrum : normal or atrophic before surgery
Secondary biochemical assay of the level of TIMP biochemical assay of the level of TIMP 1 day
Secondary biochemical assay of the level of MMPs biochemical assay of the level of MMPs 1 day
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