Clinical Study of a Novel Drug-Eluting Balloon for Obstructive Eustachian Tube Dysfunction

Randomized, Open, Parallel Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Novel Drug-Eluting Balloon for the Treatment of Obstructive Eustachian Tube Dysfunction

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100044741

Enrollment

Unknown

Registered

2021-03-26

Start date

2021-03-29

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

Chronic obstructive eustachian tube dysfunction, Chronic secretory otitis media

Interventions

Group 1:Eustachian tube balloon dilation

Group 2:eustachian tube drug-eluting balloon dilation

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.The investigators believe that the patients have other situations that are not suitable for participating in this study.

Design outcomes

Primary

Measure	Time frame
ETS score;	—

Secondary

Measure	Time frame
Acoustic immittance measurement;Valsalva test;Pure tone audiometry;	—

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