Confirmatory clinical trial of PET001 for severe cases of patulous Eustachian tube. - PET001

Toshimitsu Kobayashi0 个研究点目标入组 30 人开始时间: 2017年5月19日最近更新: 2023年10月17日

适应症

试验速览

This study revealed the efficacy and safety of silicone plug insertion for severe PET patients.

•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

•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

发起方

Toshimitsu Kobayashi