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A New Phototubometry

Evaluation of the Usefulness and Safety of a New Phototubometry System

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062190003
Enrollment
80
Registered
2019-05-29
Start date
2022-11-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

External and middle ear diseases

Interventions

In the external and middle ear diseases group, Phototubometry is performed simultaneously with Sonotubometry for normal examination. In the control group, Phototubometry and Sonotubometry are performe

Sponsors

Yazama Hiroaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Evaluation of the results of a Phototubometry System for the external and middle ear diseases (e.g. patulous Eustachian tube, otitis media with effusion, adhesive otitis media, cholesteatoma, external auditory canal stenosis, tympanosclerosis, otosclerosis, perilymph fistula, cholesterin granuloma, etc.).

Secondary

MeasureTime frame
Safety including adverse events and Side Effects through examination. During the Sonotubometry and Phototubometry, Changes in the Eustachian tube function are examined while adding external factors (e.g. rest position, swallowing, breath-holding, vowel production,). Relevance between the sence of resistance at the Eustachian tube and the results of Sonotubometry and Phototubometry,

Contacts

Public ContactHiroaki Yazama

Tottori University Hospital

h-yazama@med.tottori-u.ac.jp+81-859-38-6627

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026