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Evaluation of the Tympanic Antrum Enlargement Procedure in Meniere's Disease: A Multicenter Randomized Clinical Trial

The Development and Promotion of Innovative Multidimensional Interventional Techniques for Refractory Inner Ear Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093237
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Meniere's Disease

Interventions

Tympanic Antrum Enlargement Group:Subjects undergoing the tympanic antrum enlargement procedure requires a postauricular incision. The procedure involves maximal removal of mastoid air cells and masto
Tympanic Antrum Enlargement Combined with Endolymphatic Sac Decompression Group:Subjects undergoing the tympanic antrum enlargement procedure requires a postauricular incision. The procedure involves

Sponsors

Peking University People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18–65 years; 2) No gender restrictions; 3) Diagnosed with Meniere’s disease and with confirmed vertigo episodes in the past six months; 4) Strong desire for surgery and able to tolerate the procedure; 5) Able to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Presence of other identifiable causes of vertigo, such as sudden deafness, large vestibular aqueduct syndrome, trauma or tumor; 2) Severe underlying conditions, such as heart disease or hematological disorders, that preclude tolerance to general anesthesia, as well as pregnancy or lactation; 3) Central disorders potentially affecting vestibular function, such as Alzheimer’s disease; 4) Inability to cooperate in completing the full range of study assessments; 5) Current use of medications or treatments that may impact vestibular function.

Design outcomes

Primary

MeasureTime frame
Vertigo episodes;

Secondary

MeasureTime frame
Vestibular function;hearing;Tinnitus;

Countries

China

Contacts

Public ContactHongwei Zheng

Peking University People's Hospital

zhenghongwei@pku.edu.cn+86 136 9922 5582

Outcome results

None listed

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