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Clinical study of betamethasone drug-coated balloon catheter in the treatment of chronic secretory otitis media

Randomized, open, parallel controlled clinical trial to evaluate the safety and efficacy of betamethasone drug-coated balloon catheters in the treatment of chronic secretory otitis media

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049318
Enrollment
Unknown
Registered
2021-07-30
Start date
2021-07-30
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

Chronic secretory otitis media

Interventions

Eustachian tube drug-eluting balloon dilation group:Eustachian tube drug-eluting balloon dilation
Eustachian tube balloon dilation group:Eustachian tube balloon dilation

Sponsors

Shandong Second Provincial General Hospital (Shandong Ent Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 70 years (including borderline values), and the gender is not limited; 2.Chronic obstructive eustachian tube dysfunction; 3.Chronic secretory otitis media; 4.Eustachian tube score (ETS) <= 5.

Exclusion criteria

Exclusion criteria: 1.Allergic history to betamethasone or medical soybean phospholipid; 2.Sensorineural deafness; 3.Abnormal opening of eustachian tube or other eustachian tube diseases were identified; 4.Other nasal, sinus or ear disease eligible for surgical treatment; 5.Operation history of middle ear, nasal cavity and nasopharynx; 6.History of cleft palate or other deformities or related surgical repair; 7.History of head or neck surgery or radiotherapy; 8.The expected survival time of malignant tumor is less than 12 months; 9.There are postoperative use of glucocorticoid treatment related diseases; 10.The investigators believe that the patients have other situations that are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Effective treatment of eustachian tube dysfunction;

Secondary

MeasureTime frame
Acoustic conductance test of affected side;Recovery rate of eustachian tube blowing test;Air-bone difference (pure tone audiometry);Eustachian tube dysfunction rating scale;Hearing Impairment Quality of Life Rating Scale;

Countries

China

Contacts

Public ContactLi Li

Shandong Second Provincial General Hospital (Shandong Ent Hospital)

honey-ly@126.com+86 15168863996

Outcome results

None listed

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