Middle ear pressuretreatment by EFET01 in patients with atypical Meniere's disease
- Conditions
- Atypical Meniere's diseaseMeniere's disease, Atypical case, EFET01, Middle ear pressure treatment
- Registration Number
- JPRN-jRCTs042230155
- Lead Sponsor
- Takakura Hiromasa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1) Patient aged between 18 and 80 years old
2) Untreated patient who was diagnosed as atypical Meniere's disease based on the Clinical practice guidelines for Meniere's disease and delayed endolymphatic hydrops 2020
3) Patient who understands treatment method and procedure and is able to agree in writing of his own free will
4) Patinet who can use EFET01 correctly at home
5) Patient that conservative treatment is invalid
1) Patient using life support dispute
2) Patient using cardiac pacemarker and implantale defibrillator
3) Patient who has disase or injury in auricle and/or external auditory canal
4) Patient with tympanic membrane perforation
5) Patient unable to comply treatment method and procedure
6) Patient who was evaluated as ineligible person by doctor in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of vertigo attacks in 4 weeks based on vertigo symptom calendar
- Secondary Outcome Measures
Name Time Method ever of vertigo attacks, subjective distress and activity level in 4 weeks based on vertigo symptom calendar