ACTRN12618001681246尚未招募未知
A Randomised Control Trial assessing improvement in objective and subjective measures of Eustachian tube function after Transnasal Balloon Dilatation for Eustachian Tube obstruction.
Kolling Deafness Research Centre0 个研究点目标入组 60 人开始时间: 2018年10月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 22 Years 至 o limit（—）
- 性别
- All
入选标准
- •To be eligible to enroll in the study patients must:
- •Provide informed consent to participate in the study
- •Have a diagnosis of persistent ETDD (A positive diagnosis is confirmed by the presence of abnormal tympanometry and symptomatic dysfunction as documented by the ETDQ-7 questionnaire mean item score greater than 2.1, for 12 weeks or more prior to enrollment in the study)
- •Be 22 years of age or older with persistent ETDD and have failed medical management consisting of either 4 weeks of continuous daily usage of intranasal corticosteroids spray or a minimum of 1 completed course of oral steroids within 90-days prior to study enrollment.
- •Have a recent (or be able to undergo a) CT petrous temporal bone
- •Be able to undergo fibreoptic nasendoscopy
排除标准
- •Exclusion criteria include the following:
- •Anatomy that requires an adjunctive surgical procedure
- •Planned concomitant nasal, sinus or ear procedures during the study
- •History of major head and neck surgery within 4 months or randomization
- •History of head and neck radiation
- •Diagnosis of patulous eustachian tube
- •Fluctuating sensorineural hearing loss
- •Active acute or chronic otitis media
- •Tympanic membrane perforation or the presence of a tympanostomy tube (grommet)
- •Presence of tympanosclerosis
- •Acute upper respiratory tract infection
- •Active temporomandibular joint disorder
- •Cleft palate or a history of cleft palate repair
- •History of craniofacial syndrome
- •History of cystic fibrosis
- •History of ciliary dysmotility syndrome
- •History of systemic mucosal diseases or immunodeficiency disorders
- •Intolerance of protocol-defined medication regimen
- •Prior surgical ET intervention
- •Limited dilatory muscular contractions on endoscopy of the ET
- •Contraindications to BDET
研究者
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