severe cases of patulous Eustachian tube
Conditions
Interventions
Intervention type:DEVICE
Name of intervention:Implant of PET001
Dose form / Japanese Medical Device Nomenclature:DEVICE
not yet determined
Route of administration / Site of application:INTRATYMPANIC (
Sponsors
Toshimitsu Kobayashi
Tetsuaki Kawase, Takeshi Oshima, Kunihiro Mizuta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Definitive PET patients based on diagnostic criteria proposed by the Japan Otological Society on 2016. 2. The patients who does not improved conservative treatment for at least 6 months. 3. The patients whose PHI 10 score are more than 26 points. 4. The patient whose hearing level are under 30dB. 5. Subjects who can make self-judgment and are voluntarily giving written informed consent 6. Males and females aged 20 years old 7. Patients who are able to adhere to the study schedules during the study period, either by scheduled outpatient visits
Exclusion criteria
Exclusion criteria: 1. The patients who have external auditory or middle ear infection within 6 months. 2. Females who are pregnant or have possibility of pregnancy 3. The patients who have xylocaine or lidocaine allergy. 4. Only hearing patients. 5. The patients who have tympanic membrane perforation. 6. The patients who can not visit hospitals by themselves. 7. The patients who take steroid or immunosuppressing agent. 8. The patients who have some of the materials in middle ear. 9. Enrollment in another trial involving an investigational product 10. The patient who are inappropriate for participating in the study in the judgment of the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The PHI 10 score at 3 months after operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Eustachian tube function test (Sonotubometry, TTAG) Tympanic membrane and otoscope findings | — |
Countries
Japan
Contacts
Public ContactRyoukichi Ikeda
Sen-En Rifu Hospital
Outcome results
None listed