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Clinical Trials/JPRN-jRCTs062190003
JPRN-jRCTs062190003
Recruiting
Phase 1

Evaluation of the Usefulness and Safety of a New Phototubometry System

Yazama Hiroaki0 sites80 target enrollmentMay 29, 2019

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Yazama Hiroaki
Enrollment
80
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 29, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Yazama Hiroaki

Eligibility Criteria

Inclusion Criteria

  • Ear disease group:
  • 1\) Male and female aged 20 to 80 years old at the time of acquisition.
  • 2\) Patients have the external or middle ear disease (chronic otitis media, otitis media with effusion, adhesive otitis media, cholesteatoma, ear canal stenosis, tympanic sclerosis, otosclerosis, perilymph fistulas, cholesterin granuloma, etc.) or suspected the Eustachian tube dysfunction indicated by diagnostic criteria.
  • 3\) Patients require the Eustachian tube dysfunction test by sonotubometry.
  • 4\) Patients got consent from himself / herself.
  • Control group:
  • 1\) Male and female aged 20 to 80 years old at the time of acquisition.
  • 2\) There is no ear / sinus disease before, no one has subjective symptoms related to ears.
  • 3\) Persons do not have subjective symptoms, no abnormality was found at physical examination, and were judged healthy by the reseach director.
  • 4\) Persons got consent from himself / herself.

Exclusion Criteria

  • Ear disease group:
  • 1\) Patients have been treated for the Eustachian tube dysfunction with Eustachian tube massager, nose drops, or Eustachian tube obstruction procedure.
  • 2\) Lidocaine allergy
  • 3\) There are malformations and diseases in the nasal cavity or nasopharynx
  • 4\) Patients were judged inappropriate by the research director.
  • Control group;
  • 1\) Persons have been treated for the Eustachian tube dysfunction with Eustachian tube massager, nose drops, or Eustachian tube obstruction procedure.
  • 2\) Lidocaine allergy
  • 3\) There are malformations and diseases in the nasal cavity or nasopharynx
  • 4\) Persons were judged inappropriate by the research director.

Outcomes

Primary Outcomes

Not specified

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