Efficacy of Local Overpressure Treatment for Meniere's Disease
NCT ID: NCT00831688
Last Updated: 2009-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2005-08-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Local overpressure treatment
Meniett(C) device by MedTronic
pulsed pressure application, up to 12 cm H20 column, 3 times daily for 5 minutes, generated by Meniett device and conducted to middle ear cavity via tympanostomy tube
2
Placebo treatment
placebo treatment
device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.
Interventions
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Meniett(C) device by MedTronic
pulsed pressure application, up to 12 cm H20 column, 3 times daily for 5 minutes, generated by Meniett device and conducted to middle ear cavity via tympanostomy tube
placebo treatment
device seemingly identical to active device, manufactured by Medtronic. 3 times daily for 5 minutes.Produces similar sound effect, but without pulsed pressure elevation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Klinikum der Universitaet Muenchen, Grosshadern
OTHER
Responsible Party
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Klinikum der Universitaet Muenchen, Grosshadern
Principal Investigators
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Eike Krause, MD
Role: PRINCIPAL_INVESTIGATOR
LMU Munich, Department of ENT
Robert Gürkov, MD
Role: PRINCIPAL_INVESTIGATOR
LMU Munich, Department of ENT
Locations
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Klinik für Hals-Nasen-Ohrenheilkunde
München, Bavaria, Germany
Countries
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Other Identifiers
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Meniere trial 037/05
Identifier Type: -
Identifier Source: org_study_id
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