Skip to content

A Prospective Multicenter Randomized Controlled Study for the Evaluation of Efficacy and Safety of Balloon Eustachian Tuboplasty for Patients with Chronic Otitis Media due to Obstructive Tube Dysfunction

A Prospective Multicenter Randomized Controlled Study for the Evaluation of Efficacy and Safety of Balloon Eustachian Tuboplasty for Patients with Chronic Otitis Media due to Obstructive Tube Dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005817
Enrollment
200
Registered
2021-01-25
Start date
2021-01-19
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

Procedure/Surgery : Balloon Eustachian tuboplasty and active control treatment are prescribed at the same time. Two weeks after balloon Eustachian tuboplasty, we examine the surgical site and whether

Sponsors

University of Ulsan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patients over 19 years and under 80 years ? Patients with chronic otitis media (including exudative otitis media and chronic otitis media with cholesteatoma) associated with Eustachian tube dysfunction for more than 6 months ? In the case of a person who has previously undergone ventilation tube insertion, mastoidectomy, or tympanoplasty, patients with middle ear effusion or deterioration of Eustachian tube function continuously for at least 1 month after surgery ? In case the patient agrees to participate in clinical research and signs the written consent

Exclusion criteria

Exclusion criteria: ? Patulous Eustachian tube dysdunction patients ? Patients with fluctuating sensorineural hearing loss ? Patients with acute otitis media ? Patients with a history of cleft palate or cleft palate surgery ? Patients with a history of craniofacial deformities ? Patients who are pregnant or nursing ? In case of wanting alternative treatment (conservative treatment or ventilation tube insertion) ? If the investigator judges that the patient is not suitable for this clinical trial or may increase the risk related to participation in the study

Design outcomes

Primary

MeasureTime frame
Valsava maneuver

Secondary

MeasureTime frame
ETDQ-7

Countries

Korea, Republic of

Contacts

Public ContactYE SEUL KIM

Asan Medical Center

wd11111@naver.com+82-2-3010-3711

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026