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Single-arm, multi-centric clinical trial of Drug Delivery Catheter of Disposable double lumen eustachian tube balloon catheter

Single-arm, multi-centric clinical trial of Drug Delivery Catheter of Disposable double lumen eustachian tube balloon catheter

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065533
Enrollment
Unknown
Registered
2022-11-08
Start date
2022-03-07
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Diseases related to eustachian tube disorders

Interventions

experimental group:more than 0.7ml saline + organic iodide medium 0.2-0.4ml

Sponsors

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. select patients who are out-patient or hospitalized in the hospital; 2. Gender is not limited; 3. Age distribution of subjects: 7-75 years old; 4. Diagnose related diseases with eustachian tube dysfunction (such as secretory otitis media, cronic suppurative otitis media, etc.) Patients who need balloon dilatation of eustachian tube and drug injection through eustachian tube; 5. After the patient fully understands the purpose and steps of the trial, sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. acute upper respiratory tract infection; 2. nosebleeds; 3. Nasopharyngeal suppurative inflammation does not remove pus, nasopharyngeal ulcer and tumor; 4. Abnormal opening of eustachian tube; 5. People who are allergic to iodine; 6. The clinical condition is too serious to insist on completing the test; 7. Those who do not sign the informed consent form; 8. There are other situations that researchers think are not suitable for this clinical study.

Design outcomes

Primary

MeasureTime frame
Normal rate of injection channel;Injection arrival rate;

Countries

China

Contacts

Public ContactSuijun Chen

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

chensuijun1974@163.com+86 13609757219

Outcome results

None listed

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