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ISRCTN
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ISRCTN02147658
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ClinicalTrials.gov identifier
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Public title
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Balloon Eustachian Tuboplast (BET)
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Scientific title
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Effect of Balloon dilatation on Eustachian Tube dysfunction: a randomised controlled study
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Acronym
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BET
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Serial number at source
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N/A
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Study hypothesis
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Long-term Eustachian tube dysfunction is associated with damage to the eardrum and middle-ear transformer mechanism. Symptoms of this are: muffled hearing, pain, a feeling of fullness in the ear. Tinnitus or dizziness may also occur.
Hypothesis:
Dilating the eustachian tube should improve its function and improve middle ear function thus reducing the incidence of diseases like glue ear etc
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Lay summary
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Lay summary under review
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Long-term Eustachian tube dysfunction
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Participants - inclusion criteria
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Patients with eustachian tube dysfunction identified in the clinic will be invited to participate
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Participants - exclusion criteria
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1. Children
2. Active nasal disease e.g. polyps, deviated septum
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Anticipated start date
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04/01/2012
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Anticipated end date
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04/01/2015
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200
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Interventions
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Patients who has problems with both Eustachian tubewill be randomized to decide which side (right or left) to dilate. A tympanostomy tube(also known as a ventilation tube or grommet) will be inserted in the other ear.
A balloon catheter is introduced into the Eustachian tube via the nose, under transnasal endoscopic vision. Once the balloon is correctly positioned in the cartilaginous and bony portion of the Eustachian tube, it is filled with saline up to a pressure of about 10 bars. Pressure is maintained for approximately 2 minutes. The balloon is then emptied and removed
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Primary outcome measure(s)
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Eustachian tube score (ear popping during swallowing and blowing the ears) at 1 to 2 week before dilatation and at 1 week, 1 month, 3 months, 6 months 12 months and 24 months after dilatation
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Secondary outcome measure(s)
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1. Pure tone audiometry
2. Tympanometry
Measured at 1 to 2 week before dilatation and at 1 week, 1 month, 3 months, 6 months, 12 months and 24 months after dilatation
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Sources of funding
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North Bristol NHS trust (UK)
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Trial website
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Publications
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Contact name
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Mrs
Adenike
Oluwasanmi
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Address
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ENT Department
Southmead Hospital
Westbury on Trym
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City/town
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Bristol
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Zip/Postcode
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BS10 5NB
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Country
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United Kingdom
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Tel
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+44(0)7985 544 850
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Fax
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+44(0)117 323 5850
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Email
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Adenike.Oluwasanmi@nbt.nhs.uk
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Sponsor
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North Bristol NHS Trust (UK)
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Address
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ENT Department
Southmead Hospital
Westbury on Trym
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City/town
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Bristol
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Zip/Postcode
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BS10 5NB
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Country
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United Kingdom
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Tel
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+44 (0)117 950 5050
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Fax
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+44 (0)117 323 5850
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Email
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Adenike.Oluwasanmi@nbt.nhs.co.uk
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Sponsor website:
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http://www.nbt.nhs.uk
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Date applied
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02/12/2011
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Last edited
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04/01/2012
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Date ISRCTN assigned
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28/12/2011
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